13 results · 39ms · 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.

Pedimax II - Pedicular Screw Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

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

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·July 25, 2018

COVIDIEN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

COVIDIEN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·October 15, 2014

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 27, 2011

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 20, 2013

8120 ALARIS PCA

FDA Adverse Event
Malfunction ·CAREFUSION·Product code FRN·September 11, 2020

EXPRESSEW III W/HOOK

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code LXH·April 5, 2021

Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter

FDA Enforcement
Class II ·Terminated·Zimmer, Inc.·September 10, 2014