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

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Ampa One System (AMPA-001)

FDA 510(k)
FDA Class 2 ·Neurology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517302861·CoRoent XL-K Keel Cutter, 10mm Long

SALTI 3.5mm Medial Distal Tibia Plate, 14 Hole, Left

FDA UDI
Bonebridge AG·07640187462449·

GIBSON HEALTHCARE

FDA UDI
BENCO DENTAL SUPPLY CO.·00366975012623·Collagen wound dressing, 2 cm x 4 cm x 3 mm

Kleiner KG2 system

FDA UDI
Baat Medical Products B.V.·08720246783032·Trial

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192329·Revision Knee Reamer Spiral Fluted - Zimmer 21mm

Sterile Auto-Disable Syringes with/without Needle for Single Use

FDA 510(k)
FDA Class 2 ·General Hospital

The Micro Screw System, Micro Screw System Basic

FDA 510(k)
FDA Class 2 ·Dental

DRILL, AO, STERILE 4, 2X340 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

NA

FDA UDI
aap Implantate AG·04042409261268·Cortical Screw 2.5, small head T8, self-tapp. L 10

1.5MM CANN. QUICK RELEASE DRIVER TIP

FDA Adverse Event
Malfunction ·ACUMED, LLC·Product code LXH·June 14, 2024

1.5MM CANN. QUICK RELEASE DRIVER TIP

FDA Adverse Event
Malfunction ·ACUMED, LLC·Product code LXH·June 14, 2024

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·ACUMED, LLC·Product code HWC·June 14, 2024

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·May 28, 2025

UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code MOQ·November 14, 2014

EON MINI IPG, 16-CHANNEL RECHARGEABLE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 12, 2011

2520274-2013-04657

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·July 29, 2013

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

FDA Enforcement
Class II ·Ongoing·ARROW INTERNATIONAL, LLC·April 29, 2026

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. The Arrow Combined Spinal Anesthesia and Epidural Catheterization products permit access to subarachnoid and epidural spaces. The Arrow Single Shot Epidural product permits access to the epidural space..

FDA Enforcement
Class II ·Ongoing·ARROW INTERNATIONAL, LLC·April 29, 2026

TAPERLOC 133 FP TYPE1 PPS HO 5.0 T1

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·March 30, 2020