16 results · 24ms · 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.

Rachel's Remedy

FDA 510(k)
FDA Class 1 ·Physical Medicine

AGXO

FDA UDI
Oticon A/S·05707131284822·H150V2, MINIRITE 312 WL SGR AGXO

Trial Cage 25deg 18M

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066765·

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

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

MODIFICATION TO: EXPORT CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZOLL IVTM ICY CATHETER

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION·Product code NCX·January 19, 2021

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2018

AMISTEM H HA COATED LAT STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·July 29, 2015

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 7, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

OT VERIO REFLECT METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE GMBH·Product code NBW·February 9, 2024

TRAC KNEE TIBIAL BEARING ARCOM UHMWPE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 30, 2018

OT VERIO REFLECT METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE GMBH·Product code NBW·February 9, 2024

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024