13 results · 19ms · 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.

CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)

FDA 510(k)
FDA Class 2 ·Hematology

Medline Industries, Inc.

FDA UDI
MEDLINE INDUSTRIES, INC.·10888277999114·DISPOSABLE FACE MASK KIT

MEDICAL GLOVE SERIES

FDA 510(k)
FDA Class 1 ·General Hospital

Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

G7 OSSEOTI

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 31, 2025

ENDOPATH 5MM CURVED SCISSORS

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 13, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 11, 2010

UNKNOWN NECK

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 6, 2012

UNKNOWN SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2026

UNKNOWN SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2026

UNKNOWN SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 25, 2026

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026