22 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SANICLAVE 200

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526799387·MANUMED ACTIVE WRIST LEFT SAND XS

ALIF Disc Prep

FDA UDI
Life Spine, Inc.·00190837080136·

28mm x 11mm x 11mm Oblique with Inserter

FDA UDI
XENCO MEDICAL LLC·B064XM01128111·28mm x 11mm x 11mm Straight TLIF with Inserter

28mm x 11mm x 11mm Straight Titanium TLIF with Inserter and Tamp

FDA UDI
XENCO MEDICAL LLC·B064XMTL1112811·

28mm x 11mm x 11mm Straight Titanium TLIF with Inserter and Tamp

FDA UDI
XENCO MEDICAL LLC·B064XMTL11128111·

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

AOS ORION IR-192 SOURCE CABLE

FDA 510(k)
FDA Class 2 ·Radiology

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

MBT CEM KEEL TIB TRAY SZ4

FDA Adverse Event
Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 18, 2011

HEARTSTRING III SYSTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code DXC·October 24, 2024

HEARTSTRING III SYSTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·October 7, 2024

HEARTSTRING III SYSTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code DXC·October 4, 2024

HST III SYSTEM (4.3MM)

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code DXC·December 9, 2024

HEARTSTRING III SYSTEM 4.3MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code DXC·October 4, 2024

HEARTSTRING III SYSTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code DXC·November 12, 2024

Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK

FDA Enforcement
Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Alcon Custom Ophthalmic Surgical Procedure Packs

FDA Enforcement
Class II ·Terminated·Alcon Research, LLC·April 7, 2021