| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K073284 |
11/21/2007 |
AIR-FLOW MASTER STANDARD |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
SUSAN M BONAPACE |
| K073296 |
11/23/2007 |
TEMPXN28 |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K073322 |
11/26/2007 |
FOX 1-980, FOX Q-1064, FOX-Q-810 |
A.R.C. LASER GMBH |
KIRSTEN H PAULSON |
| K073202 |
11/13/2007 |
ARDIS SPACER |
ABBOTT SPINE, INC. |
MARITZA ELIAS |
| K073120 |
11/05/2007 |
ACCIN PATELLOFEMORAL SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K073276 |
11/21/2007 |
IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
KERI YEN |
| K073343 |
11/28/2007 |
ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K073233 |
11/15/2007 |
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS |
ADVANCED BIO-SURFACES, INC. |
PHILIP B JARVI |
| K073197 |
11/13/2007 |
SILVER ANTIMICROBIAL WOUND GEL |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K073170 |
11/09/2007 |
R-PORT II LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
MARY MCNAMARA-CULLINANE |
| K073168 |
11/09/2007 |
AESCULAP PRIMELINE CONTAINER LTD. |
AESCULAP, INC. |
KATHY A RACOSKY |
| K073271 |
11/21/2007 |
ORTHOGON |
AGFA HEALTHCARE CORPORATION |
TOM HOLBROOK |
| K073227 |
11/15/2007 |
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 |
AIIA COMMUNICATION INC. |
DANIEL KAMM |
| K073223 |
11/15/2007 |
S-TEST C02 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K073171 |
11/09/2007 |
RESUSCITATION TIMER, MODEL L770-CPR |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K073125 |
11/06/2007 |
VALEO VBR |
AMEDICA CORP. |
ADAM HERDER |
| K073219 |
11/15/2007 |
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K073137 |
11/07/2007 |
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEEN |
| K073265 |
11/20/2007 |
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM |
APIERON, INC. |
RICHARD LOTTI |
| K073149 |
11/08/2007 |
MENISCAL CINCH |
ARTHREX, INC. |
SALLY FOUST |
| K073258 |
11/20/2007 |
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K073205 |
11/13/2007 |
NIO 5MP, MODEL MDNG-5121 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K073184 |
11/13/2007 |
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K073326 |
11/27/2007 |
NRG TRANSSEPTAL NEEDLE |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K073262 |
11/20/2007 |
BELLA |
BEEKLEY CORP. |
MARTINE M BOUTTE |
| K073299 |
11/23/2007 |
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE |
BETELCARE SDN BHD |
KENG BENG SIAH |
| K073368 |
11/30/2007 |
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT |
BICON, LLC |
VINCENT J MORGAN |
| K073360 |
11/30/2007 |
PROPLATE |
BIO PROTECH, INC. |
E.J. Smith |
| K073307 |
11/23/2007 |
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM |
BIO-TECHNOLOGY USA, INC. |
IAN GORDON |
| K073341 |
11/28/2007 |
GENEX PUTTY |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K073268 |
11/20/2007 |
BIOHORIZONS INTERNAL IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K073282 |
11/21/2007 |
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K073146 |
11/08/2007 |
PADNET+ |
BIOMEDIX, INC. |
WILLIAM ROGERS |
| K073091 |
11/01/2007 |
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K073083 |
11/01/2007 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K073345 |
11/28/2007 |
CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT |
BIOMET 3I, INC. |
PRISCILLA CARO |
| K073102 |
11/02/2007 |
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K073230 |
11/15/2007 |
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K073318 |
11/26/2007 |
BIPORE BALLOON DILATION CATHETER |
BIPORE, INC. |
KEITH PALUCH |
| K073263 |
11/20/2007 |
PRO-V |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K073316 |
11/26/2007 |
CERAMENT BONE VOID FILLER, MODEL A0210 |
BONESUPPORT AB |
ANN-CHRISTINE PROVOOST |
| K073266 |
11/20/2007 |
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
NEIL KELLY |
| K073082 |
11/01/2007 |
CPS COURIER GUIDEWIRE |
BRIVANT, LTD. |
TOMAS FUREY |
| K073199 |
11/13/2007 |
3M ESPE LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
JOHN GREENBAUM |
| K073222 |
11/15/2007 |
MODIFICATION TO:SPECIALTY NEEDLES |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K073090 |
11/01/2007 |
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K073226 |
11/15/2007 |
CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
C2M MEDICAL, INC. |
GABRIELE G NIEDERAUER |
| K073123 |
11/06/2007 |
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K073304 |
11/23/2007 |
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K073194 |
11/13/2007 |
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS |
CARDIOVASCULAR IMAGING SOLUTIONS LTD. |
CARL THOMAS |
| K073207 |
11/13/2007 |
OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 |
CELON AG MEDICAL INSTRUMENTS |
LAURA STORMS-TYLER |
| K073213 |
11/14/2007 |
THERABOND ANTIMICROBIAL BARRIER SYSTEMS |
CHOICE THERAPEUTICS |
HOWARD M HOLSTEIN |
| K073334 |
11/28/2007 |
OHMNISCAN NG |
CHRISTINE VALMY INC |
PETER DEHAYDU |
| K073180 |
11/13/2007 |
SMARTSPONGE PLUS SYSTEM |
CLEARCOUNT MEDICAL SOLUTIONS, INC. |
JEFF WOLFGONG |
| K073336 |
11/28/2007 |
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 |
Codman & Shurtleff, Inc. |
EMILY E VALERIO |
| K073124 |
11/06/2007 |
COLLIMARE COLLIMATOR FAMILY |
COLLIMARE, LLC |
HOWARD C THOMAS |
| K073122 |
11/06/2007 |
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
DEBORA STAPLETON |
| K073164 |
11/09/2007 |
IVS TUNNELLER DEVICES |
COVIDIEN UK MANUFACTURING LTD |
SHARON ALEXANDER |
| K073242 |
11/19/2007 |
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 |
DELPHI MEDICAL SYSTEMS |
GILBERT ROQUE |
| K073218 |
11/15/2007 |
MTA ADVANCED MATERIAL |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K073173 |
11/13/2007 |
SELF-ADHESIVE RESIN CEMENT |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K073117 |
11/05/2007 |
DENTIN DESENSITIZER AGENT |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K073281 |
11/21/2007 |
CAIS STAPLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FORSTADT |
| K073364 |
11/30/2007 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073126 |
11/06/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073260 |
11/20/2007 |
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 |
DEVICE PARTNERS INTERNATIONAL |
MONICA E DOUGHERTY |
| K073118 |
11/05/2007 |
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM |
DIAGNOSTIC DEVICES INC. |
ERICA LI |
| K073163 |
11/09/2007 |
LIMITED ARTIFACT SKULL PIN, MODEL 0107 |
DINKLER SURGICAL DEVICES, INC. |
CHARLES E DINKLER II |
| K073113 |
11/05/2007 |
INFINITY PICCO POD, MODEL MS16734 |
Draeger Medical Systems, Inc. |
GENCI OMARI |
| K073331 |
11/27/2007 |
DVO EXTENDED ARTICULATION HUMERAL HEADS |
DVO EXTREMITY SOLUTIONS, LLC |
JEFF ONDRLA |
| K073116 |
11/05/2007 |
EBI INTERNAL IMPLANT SYSTEM |
EBI, INC. |
DANIEL KAMM |
| K073221 |
11/15/2007 |
CADENCE II |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K073340 |
11/28/2007 |
COLOR LCD MONITOR, FLEXSCAN MX300W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K073166 |
11/09/2007 |
ENDOWAVE INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K073267 |
11/20/2007 |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K073096 |
11/01/2007 |
ANCHORAGE CLOSURE DEVICE |
EPITEK, INC. |
WERNER HAMPL |
| K073288 |
11/21/2007 |
ETHICON ENDO SURGERY ARTICULATING SNARE |
ETHICON ENDO-SURGERY, INC. |
GLENDA C MARSH |
| K073317 |
11/26/2007 |
STARLIGHT, MODEL PD9012 |
F.P. RUBINSTEIN Y CIA S.R.L. |
HAYDEE N DEMARCO |
| K073339 |
11/28/2007 |
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR |
FENWAL, INC. |
TAMMY DAVIS |
| K073251 |
11/19/2007 |
HYALOMATRIX PA |
FIDIA ADVANCED BIOPOLYMERS SRL |
SHARON A SEGAL |
| K073289 |
11/21/2007 |
MICROSHEATH XL CATHETERS |
FLOWCARDIA, INC. |
Dustin Michaels |
| K073330 |
11/27/2007 |
FREEDOM SCIENCES MOTION CONTROL MODULE (MCM) |
FREEDOM SCIENCES, LLC |
EDWARD A KROLL |
| K073283 |
11/21/2007 |
GC GAM-100 |
GC AMERICA, INC. |
MARK HEISS |
| K073106 |
11/02/2007 |
UNIFAST III |
GC AMERICA, INC. |
MARK HEISS |
| K073138 |
11/07/2007 |
CARDIQ EXPRESS VERSION 2.0 |
GE MEDICAL SYSTEMS |
STEPHEN SLAVENS |
| K073203 |
11/13/2007 |
CARESCAPE V100 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN RUSSELL |
| K073153 |
11/08/2007 |
CARDIQ FUNCTION XPRESS |
GE MEDICAL SYSTEMS SCS |
|
| K073167 |
11/09/2007 |
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER |
GE MEDICAL SYSTEMS, LLC |
|
| K073297 |
11/23/2007 |
GE LOGIQ P6 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K073154 |
11/08/2007 |
FACTS HAND AND PINCH GRIP COMBO |
GLOBAL SERVICES GROUP, LLC |
RAY GAGNE |
| K073172 |
11/13/2007 |
BEACON STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K073246 |
11/19/2007 |
ZENIEVA |
GORBEC PHARMACEUTICAL SERVICES, INC. |
SANDRA R KIRCUS |
| K073182 |
11/13/2007 |
GYN DISPOSABLES TENACULUM 356T |
GYN-DISPOSABLES, INC. |
JAMES K PATTERSON |
| K073225 |
11/15/2007 |
SENSEI CATHETER CONTROL SYSTEM |
HANSEN MEDICAL, INC. |
DOUG WORTH |
| K073237 |
11/16/2007 |
REHASTIM & REHAMOVE |
HASOMED GMBH |
MATTHIAS WEBER |
| K073314 |
11/26/2007 |
HEANY INDUSTRIES INC DENTAL XIRCONIA |
HEANY INDUSTRIES INC |
COREY DUNN |
| K073358 |
11/29/2007 |
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A |
HEEYOUNG CO., LTD. |
CARL THOMAS |
| K073292 |
11/23/2007 |
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM |
HEEYOUNG CO., LTD. |
CARL THOMAS |
| K073310 |
11/23/2007 |
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL |
HITACHI MEDICAL CORP. |
DOUG THISTLEWAITE |
| K043617 |
11/26/2007 |
IMAGECHECKER CT CAD SOFTWARE SYSTEM |
HOLOGIC, INC. |
ARTHUR FRIEDMAN |
| K073309 |
11/23/2007 |
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT |
HORIBA ABX |
OLIVIER DUCAMP |
| K073158 |
11/08/2007 |
SCULPTURE 2.94 ER:YAG SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K073332 |
11/27/2007 |
V-RASER DIODE LASER SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K073369 |
11/30/2007 |
EI DOWNPAK BARRIER SLEEVES |
HU-FRIEDY MFG. CO., INC |
KEITH DUNN |
| K073190 |
11/13/2007 |
SLIT LAMP |
HUVITZ CO., LTD. |
CHARLIE MACK |
| K073269 |
11/21/2007 |
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM |
HYPNOCORE, LTD. |
GEORGE J HATTUB |
| K073114 |
11/05/2007 |
IMIX INSIGHT X-RAY SYSTEMS |
IMIX ADR FINLAND OY |
DANIEL KAMM |
| K073161 |
11/09/2007 |
REPLUS DENTAL IMPLANTS (HA) |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K073217 |
11/15/2007 |
INCLUSIVE IMPLANT ABUTMENTS |
INCLUSIVE DENTAL SOLUTIONS |
KEITH D ALLRED |
| K073145 |
11/08/2007 |
QUANTA LITE H-TTG SCREEN |
INOVA DIAGNOSTICS, INC. |
JOSEPH PHILLIPS |
| K073367 |
11/30/2007 |
HEMOSIL FIBRINOGEN-C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K073105 |
11/02/2007 |
PEEK SPINAL SPHERES |
INTERBODY INNOVATIONS, LLP |
J.D. WEBB |
| K073112 |
11/05/2007 |
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K073134 |
11/07/2007 |
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I |
INVACARE CORPORATION |
CARROLL MARTIN |
| K073214 |
11/14/2007 |
DUOWEDGE SYNTHETIC BONE SUBSTITUTE |
KASIOS |
J.D. WEBB |
| K073257 |
11/19/2007 |
KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
JACK PAVLO |
| K073162 |
11/09/2007 |
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING |
KENSEY NASH CORPORATION |
ROBIN FATZINGER |
| K073209 |
11/14/2007 |
MAXCEM 2 |
KERR CORPORATION |
COLLEEN BOSWELL |
| K073144 |
11/07/2007 |
LANX INTERVERTEBRAL BODY FUSION DEVICE |
LANX, LLC |
GREG CAUSEY |
| K073104 |
11/02/2007 |
SKINTACT AND VARIOUS OTHER TRADENAMES |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K073274 |
11/21/2007 |
SPINAL SPHERE SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073187 |
11/13/2007 |
PERIPHERAL NERVE BLOCK SUPPORT TRAY |
LIFE-TECH, INC. |
JEFF KASOFF |
| K073231 |
11/15/2007 |
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
KIM FONDA |
| K073248 |
11/19/2007 |
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K073179 |
11/13/2007 |
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 |
MAQUET CRITICAL CARE AB |
JAMIE YIEH |
| K073337 |
11/28/2007 |
MECTACER BIOLOX FORTE-FEMORAL HEADS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K073323 |
11/27/2007 |
SA-3000P |
MEDICORE CO., LTD. |
YOO BYUNG-KUK |
| K073156 |
11/08/2007 |
QPLAQUE MR |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K073324 |
11/27/2007 |
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R |
MEDTRONIC INC. |
BECKY HANNACK |
| K073356 |
11/29/2007 |
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 |
MEDTRONIC MINIMED |
MARK J FAILLACE |
| K073139 |
11/07/2007 |
SMALL LUMEN PERITONEAL CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K073291 |
11/23/2007 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
| K073285 |
11/23/2007 |
PEEK PREVAIL CERVICAL INTERBODY DEVICE |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHAEL SCOTT |
| K073255 |
11/19/2007 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
DAVID GUZEK |
| K073140 |
11/07/2007 |
VITALOGIK MODEL 4000/4500 |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K073110 |
11/05/2007 |
MERITS E600 SERIES STAIR LIFT |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K073198 |
11/13/2007 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K073131 |
11/06/2007 |
MICROMRI WRIST COIL |
MICROMRI, INC. |
Hrishikesh Gadagkar |
| K073300 |
11/23/2007 |
MILESMAN PREMIUM |
MILESMAN S.L. |
NATALYA VALERIO |
| K073176 |
11/13/2007 |
KANTERON DICOM STATION (KDS), MODEL 3.0 |
MONICA VEYTIA |
MONICA VEYTIA |
| K073329 |
11/27/2007 |
SYGNAL DBM |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
| K073236 |
11/16/2007 |
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE |
NEOCOIL |
BRIAN BROWN |
| K073181 |
11/13/2007 |
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL |
NEOCOIL, LLC |
BRIAN BROWN |
| K073142 |
11/07/2007 |
NOBELREPLACE HEXAGONAL IMPLANT |
NOBEL BIOCARE USA LLC |
KAM LEUNG |
| K073099 |
11/02/2007 |
FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
CONSTANCE G BUNDY |
| K073132 |
11/07/2007 |
MODEL D DISC FORCE |
NORTH AMERICAN MEDICAL CORP (NAM) |
CHELLO GRACE |
| K073088 |
11/01/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K073130 |
11/06/2007 |
SPY FLUORESCENT IMAGING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K073121 |
11/05/2007 |
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS |
NUBRACE, INC. |
JONATHAN S KAHAN |
| K073273 |
11/21/2007 |
EQUAL DOSE 1.0 |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K073107 |
11/02/2007 |
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 |
NUCLETRON CORPORATION |
LISA] DIMMICK |
| K073275 |
11/21/2007 |
NUVASIVE HELIX MINI ACP SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073278 |
11/21/2007 |
SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073293 |
11/23/2007 |
DURETTE IMPLANT |
OCULO PLASTIK, INC. |
JEAN-FRANCOIS DURETTE |
| K073150 |
11/08/2007 |
APEX-LNK POLY ACETABULAR CUP LINERS |
OMNI LIFE SCIENCE, INC. |
EDWARD J CHEAL |
| K073313 |
11/26/2007 |
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K073157 |
11/08/2007 |
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
| K073344 |
11/28/2007 |
ORTHOPEDIATRICS PLATING SYSTEM |
ORTHOPEDIATRICS, LLC |
GARY BARNETT |
| K073228 |
11/15/2007 |
DC ULNAR SHORTENING SYSTEM |
ORTHOPRO LLC |
J.D. WEBB |
| K073100 |
11/02/2007 |
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S |
Oscor Inc. |
MILA DOSKOCIL |
| K073247 |
11/19/2007 |
US/SS/GS SYSTEM |
OSSTEM IMPLANT CO LTD |
MINJOO KIM |
| K073328 |
11/27/2007 |
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA |
PAIEON, INC. |
RAVIT BARKAMA |
| K073363 |
11/30/2007 |
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 |
PALADIN BIOMEDICAL CORPORATION |
ROBERT BICKFORD |
| K073362 |
11/30/2007 |
MROPEN |
PARAMED SRL |
MICHAEL A DOUGLAS |
| K073210 |
11/14/2007 |
MODIFICATION TO: T-PORT HP INFUSION PORT |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K073089 |
11/01/2007 |
LIFEPAK 20E |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K073229 |
11/15/2007 |
NERVE MONITORING CABLE |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K073177 |
11/13/2007 |
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K073148 |
11/08/2007 |
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K073220 |
11/15/2007 |
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT |
PRESTIGE BRANDS, INC. |
KAREN A COSTA-STRACHAN |
| K073224 |
11/15/2007 |
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH |
PROCTER & GAMBLE |
MICHAEL A KAMINSKI |
| K073353 |
11/29/2007 |
DO-ALL DENTAL HANDPIECE LUBRICANT |
PRODRIVE SYSTEMS, INC. |
TIMOTHY F NASON |
| K073178 |
11/13/2007 |
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 |
R & D SYSTEMS, INC. |
NANCY C RING |
| K073349 |
11/29/2007 |
RELIANCE BUTTRESS WASHER SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K073243 |
11/19/2007 |
LED PRO SEAL |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAUL GANGE |
| K073111 |
11/05/2007 |
PORTRAIT PSR, MODEL 745915 |
RHYTEC INCORPORATED |
Robert Zoletti |
| K073277 |
11/21/2007 |
ROCHE-CREACTIVE PROTEIN (LATEX) |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
| K073342 |
11/28/2007 |
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW |
SALVIN DENTAL SPECIALTIES, INC. |
ROBERT SALVIN |
| K073206 |
11/13/2007 |
NEEDLE-TRAP/NEEDLE SAFETY LABEL |
SCHREINER MEDIPHARM |
Lee Leichter |
| K073319 |
11/26/2007 |
STATMATIC 31 HANDPIECE MAINTENANCE UNIT |
SCICAN LTD. |
BRENDA MURPHY |
| K073169 |
11/09/2007 |
SCIMAGE PICOMENTERPRISE |
SCIMAGE, INC. |
GARY J ALLSEBROOK |
| K073127 |
11/06/2007 |
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K073152 |
11/08/2007 |
PC-180 / PRINCE 180 EASY ECG MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
|
| K073366 |
11/30/2007 |
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
CHARLES MACK |
| K073280 |
11/21/2007 |
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K073193 |
11/13/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
| K073192 |
11/13/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
| K073238 |
11/16/2007 |
SYNGO VOLUME PERFUSION-CT NEURO |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K073290 |
11/21/2007 |
ARTIS ZEE AND ZEEGO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K073175 |
11/13/2007 |
JOURNEY UNICONDYLAR FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
MARLON RIDLEY |
| K073325 |
11/27/2007 |
LEGION POROUS PRIMARY |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K073188 |
11/13/2007 |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K073287 |
11/21/2007 |
PREVADH MESH |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K073249 |
11/19/2007 |
SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES |
SOLARIS MEDICAL TECHNOLOGY, INC. |
ALAN SCHWARTZ |
| K073095 |
11/01/2007 |
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
SUSANNE RAAB |
| K073196 |
11/13/2007 |
MASTER-VU |
SONOMED, INC. |
GEORGE MYERS |
| K073350 |
11/29/2007 |
SCANORA 3D |
SOREDEX PALODEX GROUP OY |
JOUNI ONNELA |
| K073351 |
11/29/2007 |
CRYSTAL |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K073348 |
11/29/2007 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K073240 |
11/16/2007 |
PSS SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
| K073320 |
11/26/2007 |
CIMPLICITY SPINAL SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| K073232 |
11/15/2007 |
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX |
SPINEFRONTIER, INC. |
THOMAS A CARLSON |
| K073093 |
11/01/2007 |
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, |
SPIRE BIOMEDICAL INC |
RAYMOND KELLY |
| K073092 |
11/01/2007 |
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, |
SPIRE BIOMEDICAL INC |
RAYMOND KELLY |
| K073244 |
11/19/2007 |
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES |
STERIS Corporation |
JOHN R SCOVILLE |
| K073361 |
11/30/2007 |
MUSCLE PAIN DEVICE (MPD) |
STEVENS PROOF OF CONCEPT, INC. |
JECKIN D SHAH |
| K073151 |
11/08/2007 |
MANTIS SPINAL SYSTEM |
STRYKER CORP. |
CURTIS TRUESDALE |
| K073109 |
11/02/2007 |
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM |
SURGICRAFT LTD. |
DONALD W GUTHNER |
| K073303 |
11/23/2007 |
NORIAN DRILLABLE |
SYNTHES (USA) |
JEFFREY L DOW |
| K073115 |
11/05/2007 |
ORTHOMESH |
SYNTHES (USA) |
JEFFREY L DOW |
| K073135 |
11/07/2007 |
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS |
SYNTHES (USA) |
JILL SHERMAN |
| K073186 |
11/13/2007 |
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K073119 |
11/05/2007 |
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
| K073311 |
11/23/2007 |
OSTEOTRANS-OT PIN |
TAKIRON CO., LTD |
KUMIHIRO HATA |
| K073312 |
11/23/2007 |
OSTEOTRANS-OT SCREW |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K073185 |
11/13/2007 |
APX21 |
TECHDENT TECHNOLOGIES, LTD. |
BENNY ARAZY |
| K073370 |
11/30/2007 |
TC MATRIX CLINICAL CHEMISTRY ANALYZER |
TECO DIAGNOSTICS |
JIM VAECHHES |
| K073094 |
11/01/2007 |
VITALLINK3 MOBILE VITAL SIGNS SYSTEM |
TELEMEDIC SYSTEMS LTD |
GERALD L BUSS |
| K073191 |
11/13/2007 |
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073355 |
11/29/2007 |
CALCIUM, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073295 |
11/23/2007 |
UREA/BUN, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073141 |
11/07/2007 |
SPI ART ABUTMENT |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K073272 |
11/21/2007 |
WORKSTATIONONE BREAST IMAGING WORKSTATION |
THREE PALM SOFTWARE, LLC |
HEIDI D ZHANG |
| K073087 |
11/01/2007 |
NON-CONTACT TONOMETER, MODEL FT-1000 |
TOMEY CORPORATION |
KOJI KUBO |
| K073165 |
11/09/2007 |
DRAD-3000E, RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073081 |
11/01/2007 |
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073259 |
11/20/2007 |
XIDF-100A/B1 IMAGE PROCESSOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073147 |
11/08/2007 |
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 |
TRANSOMA MEDICAL |
LISA STONE |
| K073159 |
11/08/2007 |
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K073097 |
11/01/2007 |
TUTODENT DENTAL MEMBRANE |
TUTOGEN MEDICAL U.S., INC. |
TRAVIS AROLA |
| K073133 |
11/07/2007 |
INTERSTITIAL NEEDLES |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K073241 |
11/16/2007 |
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM |
VASCULAR PATHWAYS |
MARY PASCUAL GALLUP |
| K073264 |
11/20/2007 |
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K073200 |
11/13/2007 |
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| K073365 |
11/30/2007 |
DENTAL DIGITAL X-RAY IMAGING SYSTEM |
VATECH CO., LTD. |
STEPHEN T MLCOCH |
| K073338 |
11/28/2007 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K073245 |
11/19/2007 |
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K073143 |
11/07/2007 |
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K073279 |
11/21/2007 |
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K073155 |
11/08/2007 |
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K073261 |
11/20/2007 |
VAR MONITOR |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K073352 |
11/29/2007 |
WEBERNEEDLE BASIC LASER |
WEBER MEDICAL GMBH |
JURGEN HERMANN |
| K073108 |
11/02/2007 |
ZENO ZR DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K073306 |
11/23/2007 |
XORANCONNECT |
XORAN TECHNOLOGIES, INC. |
AMY S KIM |
| K073346 |
11/29/2007 |
ZIEHM VISION 2 |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K073347 |
11/29/2007 |
DYNESYS TOP-LOADING SPINAL SYSTEM |
ZIMMER SPINE, INC |
ELSA A LINKE |
| K073286 |
11/21/2007 |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM |
ZIMMER, INC. |
BRANDON HIPSHER |
