| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K201966 |
07/15/2020 |
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array |
7D Surgical Inc. |
Daniel Zisind |
| K201834 |
07/02/2020 |
HI-TORQUE PROCEED Guide Wire Family |
Abbott Vascular |
Charlotte Pullman |
| K201948 |
07/13/2020 |
AcroDTI Visualizer |
AcroViz Inc. |
Yung-Chin Hsu |
| K202099 |
07/29/2020 |
AOS GalileoÖ Trochanteric Nail System |
Advanced Orthopaedic Solutions, Inc. |
Jolie Krance |
| K202124 |
07/31/2020 |
Aesculap PAS-Port Proximal Anastomosis System |
Aesculap Inc. |
Sierra Mertz |
| K202036 |
07/23/2020 |
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K201830 |
07/02/2020 |
ANSER Clavicle Pin |
Baat Medical Products BV |
Teake Bulstra |
| K202008 |
07/21/2020 |
Disposable Vinyl Glove |
Best Care Trading Co., LTD |
Chongfeng Zhao |
| K201833 |
07/02/2020 |
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords |
BiPad Surgical, Inc. |
Louis Cornacchia |
| K202050 |
07/24/2020 |
Cranial 4Pi Immobilization |
Brainlab AG |
Chiara Cunico |
| K201871 |
07/07/2020 |
Surgical Mask |
C & S Paper Yunfu Co., Ltd. |
Xu Zhiming |
| K201992 |
07/17/2020 |
Caption Guidance |
Caption Health |
Sam Surette |
| K201926 |
07/10/2020 |
CarboClear« Pedicle Screw System, CarboClear« II Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K201933 |
07/13/2020 |
ImagenSPECT 3.0 |
Cardiovascular Imaging Technologies |
James A. Case |
| K201932 |
07/13/2020 |
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) |
CareRay Digital Medical System Co., Ltd. |
Leilei Li |
| K201898 |
07/02/2020 |
Clear Guide SCENERGY |
Clear Guide Medical |
Jack Kent |
| K201859 |
07/06/2020 |
Porcine Mineral Collagen Composite Moldable |
Collagen Matrix, Inc. |
Gloria Zuclich |
| K201849 |
07/06/2020 |
eNAT molecular collection and preservation medium |
Copan Italia S.p.A. |
Elena Simeonato |
| K201851 |
07/06/2020 |
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right |
Corentec Co., Ltd |
Sungwon Yang |
| K201805 |
07/01/2020 |
VersaOne Reusable Positioning Trocar System |
Covidien |
Stephanie Wilde |
| K201952 |
07/14/2020 |
CrossGlide ETS Plus |
CrossBay Medical |
Piush Vidyarthi |
| K201831 |
07/02/2020 |
CONFIDENCE Spinal Cement System |
DePuy Spine, Inc. |
Sergio M. Cordeiro |
| K201959 |
07/14/2020 |
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System |
DePuy Synthes |
Stacey Bonnell |
| K202012 |
07/21/2020 |
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System |
Devicor Medical Products, Inc. |
Gwendolyn P. Payne |
| K202156 |
07/27/2020 |
DIAMOND-5A/6A/8A |
DRGEM Corporation |
Ki-Nam Yang |
| K201979 |
07/16/2020 |
Cervical Plate System |
Eminent Spine, LLC |
Stephen Courtney |
| K202116 |
07/30/2020 |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Ewoo soft Co., Ltd. |
Young Seok Kim |
| K202130 |
07/31/2020 |
FUJIFILM Video Laparoscope |
Fujifilm Corporation |
Randy Vader |
| K201960 |
07/14/2020 |
SpaceFlex Knee - 80mm Size |
G21 S.r.l |
Filippo Foroni |
| K201961 |
07/14/2020 |
IlluminOss Photodynamic Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K201981 |
07/16/2020 |
Magicore System |
InnoBioSurg Co., Ltd. |
Bo-Yeon Lim |
| K201938 |
07/13/2020 |
LZI Fentanyl II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K202007 |
07/21/2020 |
LZI Oxycodone III Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K201995 |
07/20/2020 |
CUBEScan BioCon-1100 |
Mcube Technology Co., Ltd. |
Hye-Ri Choi |
| K202022 |
07/22/2020 |
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) |
Medacta International SA |
Stefano Baj |
| K201829 |
07/02/2020 |
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Jennifer Mason |
| K201883 |
07/08/2020 |
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor |
Medos International SARL |
Elizabeth Messana |
| K201907 |
07/09/2020 |
ClariVein IC |
Merit Medical Systems, Inc. |
Michaela Rivkowich |
| K201807 |
07/01/2020 |
ANCORIS |
MiEGmbH |
Thomas Kuehl |
| K202072 |
07/27/2020 |
MindsEye Expandable Port |
Minnetronix Neuro, INC. |
Matt Adams |
| K201854 |
07/06/2020 |
CAPOGEN Laser Cap |
Nature Incredible Inc |
John Lee |
| K201837 |
07/02/2020 |
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge |
NeoTract, Inc. |
Brian Gall |
| K201850 |
07/06/2020 |
Vector Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K201841 |
07/02/2020 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| K201920 |
07/10/2020 |
Endoscope Reprocessor OER-Elite |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K202068 |
07/27/2020 |
The AIO Solution 3.0 |
Orfit Industries NV |
Eddy Marivoet |
| K201909 |
07/09/2020 |
RxSight Contact Lens |
RxSight, Inc. |
Maureen O'Connell |
| K202064 |
07/27/2020 |
Admiral ACP System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K202014 |
07/21/2020 |
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit |
Siemens Medical Solutions USA, Inc. |
Andrew Turner |
| K201953 |
07/14/2020 |
OMNI PLUS Surgical System |
Sight Sciences, Inc. |
Edward J. Sinclair |
| K201951 |
07/13/2020 |
Cemented Origin Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K201916 |
07/10/2020 |
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K201900 |
07/08/2020 |
3D GraftRasp System |
SurGenTec |
Andrew Shoup |
| K201944 |
07/13/2020 |
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) |
Synthes (USA) Products, LLC |
Prem Pisupati |
| K201958 |
07/14/2020 |
ETD Family of Electrotherapy Devices |
TheraSigma, LLC |
Jim Klett |
| K202108 |
07/30/2020 |
External Counterpulsation System, Soulaire |
Vamed Medical Instrument Co., Ltd. |
Ji Ma |
| K202143 |
07/31/2020 |
Dynex Micro |
Vilex, LLC |
Joyce Thacker |
| K202054 |
07/24/2020 |
Dynex Ring Fixation System, Diametrix Ring Fixation System |
Vilex, LLC |
Joyce Thacker |
| K201856 |
07/06/2020 |
Provicol QM Aesthetic |
VOCO GmbH |
M. Th. Plaumann |
