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


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