FDA 510(k) Applications for Medical Device Product Code "HDB"
(Extractor, Vacuum, Fetal)

FDA 510(k) Number Applicant Device Name Decision Date
K881306 CHALLENGE MFG., INC. CMI VACUUM DELIVERY SYSTEM #003C AND #004C 06/13/1988
K881967 CHALLENGE MFG., INC. CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) 06/13/1988
K895446 CHALLENGE MFG., INC. CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) 11/27/1989
K981260 CLINICAL INNOVATIONS, INC. KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M 09/22/1998
K942725 COLUMBIA MEDICAL & SURGICAL, INC. CMI VELVET TOUCH VACUUM EXTRACTOR 05/05/1995
K915763 COLUMBIA MEDICAL & SURGICAL, INC. MODIFIED DISPOSABLE FETAL VACUUM 03/18/1992
K771558 DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS SILASTIC BRAND OBSTETRICAL VACUUM CUP 09/20/1977
K021193 FORTUNE MEDICAL INSTRUMENT CORP. FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 02/12/2003
K911326 GESCO INTL., INC. OBSTETRICAL VACUUM CUP 08/14/1991
K891465 GO MEDICAL INDUSTRIES PTY. LTD. OBSTETRIC CUP (MODIFICATION) 05/11/1989
K840008 GOMEDICAL INDUSTRIES PTY LTD. O'NEIL OBSTETRIC CUP 04/25/1984
K980976 HOLLISTER, INC. AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP 08/21/1998
K895700 HOLLISTER, INC. AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR 04/02/1990
K041579 MEDELA AG MEDELA SINGLE USE SILC CUP, MODEL 077.0791 04/21/2005
K841492 MEDELA, INC. AB VACUUM EXTRACTOR SILC-CUP 05/07/1984
K830012 MEDELA, INC. MEDELA SUCTION PUMP 01/24/1983
K043614 MEDEVCO, INC. VACULINK, MODEL VCL 3000 04/14/2005
K890307 NEWARD ENTERPRISES, INC. MITYVAC "M" STYLE VACUUM EXTRACTOR, DISPOSABLE 03/31/1989
K960549 NEWARD ENTERPRISES, INC. MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE 08/29/1996
K943938 NEWARD ENTERPRISES, INC. MITYVAC SUPER "M" STYLE VACUM EXTRACTOR, DISPOSABLE 05/03/1995
K934011 NEWARD ENTERPRISES, INC. MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE 05/04/1994
K913324 NEWARD ENTERPRISES, INC. MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT 06/22/1992
K011532 PRISM ENTERPRISES, INC. MITYVAC 07/30/2001
K020447 PRISM ENTERPRISES, INC. MITYVAC MERLIN, MODEL 10027 04/12/2002
K980212 PRISM TECHNOLOGIES, INC. MITYVAC 07/09/1998
K970170 RICHARD G. LINDSAY SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE 03/28/1997
K973942 SWIFT DELIVERY PRODUCTS SWIFT DELIVERY PRODUCT #300 12/12/1997
K013460 SWIFT DELIVERY PRODUCTS SWIFT LOW PROFILE CUP (PRO CUP) 01/17/2002
K963287 SWIFT DELIVERY PRODUCTS VACUUM CUP (004SD) 10/28/1996


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact