24 results · 20ms · 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.

DISPOSABLE M2-PE MICROKERATOME BLADES

FDA 510(k)
FDA Class 1 ·Ophthalmic

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001717·Cervical Collar

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004011·PowerChem Neoprene Exam Gloves, Extra Small

Leksell Gamma Knife Icon

FDA UDI
Elekta Instrument AB·07340048306584·QA+ TOOL

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0104010·Caddie Lid, Trials

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0104010·Caddie Lid, Cages, Universal

Kaliec Special

FDA UDI
Kalitec Direct LLC·B073DRK0300010·Probe, 1.75" Egg, Steffee Long Str Imp Crimson

VAPOTHERM, MODEL 2000I

FDA 510(k)
FDA Class 2 ·Anesthesiology

TRI-PLEX ADAPTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

BOOMERANG PEEK FUSION DEVICE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011

TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 2, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 9, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·April 16, 2008

PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

BASE SYSTEM, ILLUMENA

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM·Product code DXT·September 16, 2025

Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.

FDA Recall
Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005

Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States.

FDA Recall
Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004