FDA 510(k) Applications for Medical Device Product Code "HDB"
(Extractor, Vacuum, Fetal)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
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 |
K021193 |
FORTUNE MEDICAL INSTRUMENT CORP. |
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 |
02/12/2003 |
K980976 |
HOLLISTER, INC. |
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP |
08/21/1998 |
K041579 |
MEDELA AG |
MEDELA SINGLE USE SILC CUP, MODEL 077.0791 |
04/21/2005 |
K043614 |
MEDEVCO, INC. |
VACULINK, MODEL VCL 3000 |
04/14/2005 |
K960549 |
NEWARD ENTERPRISES, INC. |
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE |
08/29/1996 |
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 |
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