Extractor, Vacuum, Fetal

FDA product code HDB · 30 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.4340
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-09-20 – 2025-10-08

HDB 2025-10-08

Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

Applicant Clinical Innovations, LLC

K number K250298

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HDB 2005-04-21

MEDELA SINGLE USE SILC CUP, MODEL 077.0791

Applicant Medela AG

K number K041579

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HDB 2005-04-14

VACULINK, MODEL VCL 3000

Applicant Medevco, Inc.

K number K043614

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HDB 2003-02-12

FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

Applicant Fortune Medical Instrument Corp.

K number K021193

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HDB 2002-04-12

MITYVAC MERLIN, MODEL 10027

Applicant Prism Enterprises, Inc.

K number K020447

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HDB 2002-01-17

SWIFT LOW PROFILE CUP (PRO CUP)

Applicant Swift Delivery Products

K number K013460

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HDB 2001-07-30

MITYVAC

Applicant Prism Enterprises, Inc.

K number K011532

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HDB 1998-09-22

KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M

Applicant Clinical Innovations, Inc.

K number K981260

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HDB 1998-08-21

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP

Applicant Hollister, Inc.

K number K980976

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HDB 1998-07-09

MITYVAC

Applicant Prism Technologies, Inc.

K number K980212

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HDB 1997-12-12

SWIFT DELIVERY PRODUCT #300

Applicant Swift Delivery Products

K number K973942

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HDB 1997-03-28

SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE

Applicant Richard G. Lindsay

K number K970170

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HDB 1996-10-28

VACUUM CUP (004SD)

Applicant Swift Delivery Products

K number K963287

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HDB 1996-08-29

MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE

Applicant Neward Enterprises, Inc.

K number K960549

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HDB 1995-05-05

CMI VELVET TOUCH VACUUM EXTRACTOR

Applicant Columbia Medical & Surgical, Inc.

K number K942725

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HDB 1995-05-03

MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE

Applicant Neward Enterprises, Inc.

K number K943938

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HDB 1994-05-04

MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE

Applicant Neward Enterprises, Inc.

K number K934011

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HDB 1992-06-22

MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT

Applicant Neward Enterprises, Inc.

K number K913324

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HDB 1992-03-18

MODIFIED DISPOSABLE FETAL VACUUM

Applicant Columbia Medical & Surgical, Inc.

K number K915763

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HDB 1991-08-14

OBSTETRICAL VACUUM CUP

Applicant Gesco Intl., Inc.

K number K911326

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HDB 1990-04-02

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR

Applicant Hollister, Inc.

K number K895700

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HDB 1989-11-27

CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)

Applicant Challenge Mfg., Inc.

K number K895446

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HDB 1989-05-11

OBSTETRIC CUP (MODIFICATION)

Applicant Go Medical Industries Pty. , Ltd.

K number K891465

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HDB 1989-03-31

MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE

Applicant Neward Enterprises, Inc.

K number K890307

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HDB 1988-06-13

CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)

Applicant Challenge Mfg., Inc.

K number K881967

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HDB 1988-06-13

CMI VACUUM DELIVERY SYSTEM #003C AND #004C

Applicant Challenge Mfg., Inc.

K number K881306

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HDB 1984-05-07

AB VACUUM EXTRACTOR SILC-CUP

Applicant Medela, Inc.

K number K841492

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HDB 1984-04-25

O'NEIL OBSTETRIC CUP

Applicant Go Medical Industries Pty. , Ltd.

K number K840008

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HDB 1983-01-24

MEDELA SUCTION PUMP

Applicant Medela, Inc.

K number K830012

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HDB 1977-09-20

SILASTIC BRAND OBSTETRICAL VACUUM CUP

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K771558

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