HDB

MITYVAC

Advisory panel: Obstetrics/Gynecology
Total cleared: 30

Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HDB

K250298 — 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) Clinical Innovations, LLC · 2025-10-08
K041579 — MEDELA SINGLE USE SILC CUP, MODEL 077.0791 Medela AG · 2005-04-21
K043614 — VACULINK, MODEL VCL 3000 Medevco, Inc. · 2005-04-14
K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 Fortune Medical Instrument Corp. · 2003-02-12
K020447 — MITYVAC MERLIN, MODEL 10027 Prism Enterprises, Inc. · 2002-04-12
K013460 — SWIFT LOW PROFILE CUP (PRO CUP) Swift Delivery Products · 2002-01-17
K011532 — MITYVAC Prism Enterprises, Inc. · 2001-07-30
K981260 — KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M Clinical Innovations, Inc. · 1998-09-22
K980976 — AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP Hollister, Inc. · 1998-08-21
K980212 — MITYVAC Prism Technologies, Inc. · 1998-07-09
K973942 — SWIFT DELIVERY PRODUCT #300 Swift Delivery Products · 1997-12-12
K970170 — SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE Richard G. Lindsay · 1997-03-28
K963287 — VACUUM CUP (004SD) Swift Delivery Products · 1996-10-28
K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. · 1996-08-29
K942725 — CMI VELVET TOUCH VACUUM EXTRACTOR Columbia Medical & Surgical, Inc. · 1995-05-05
K943938 — MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. · 1995-05-03
K934011 — MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE Neward Enterprises, Inc. · 1994-05-04
K913324 — MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT Neward Enterprises, Inc. · 1992-06-22
K915763 — MODIFIED DISPOSABLE FETAL VACUUM Columbia Medical & Surgical, Inc. · 1992-03-18
K911326 — OBSTETRICAL VACUUM CUP Gesco Intl., Inc. · 1991-08-14
K895700 — AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR Hollister, Inc. · 1990-04-02
K895446 — CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) Challenge Mfg., Inc. · 1989-11-27
K891465 — OBSTETRIC CUP (MODIFICATION) Go Medical Industries Pty. , Ltd. · 1989-05-11
K890307 — MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. · 1989-03-31
K881306 — CMI VACUUM DELIVERY SYSTEM #003C AND #004C Challenge Mfg., Inc. · 1988-06-13
K881967 — CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) Challenge Mfg., Inc. · 1988-06-13
K841492 — AB VACUUM EXTRACTOR SILC-CUP Medela, Inc. · 1984-05-07
K840008 — O'NEIL OBSTETRIC CUP Go Medical Industries Pty. , Ltd. · 1984-04-25
K830012 — MEDELA SUCTION PUMP Medela, Inc. · 1983-01-24
K771558 — SILASTIC BRAND OBSTETRICAL VACUUM CUP Dow Corning Corp. Healthcare Industries Materials · 1977-09-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.