21 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.

SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Neurology

NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HAW·April 19, 2017

Sani-Tip®

FDA UDI
Dentsply Professional·D0031222111·Sani-TIP Disposable Air Water Syringe Tips, 250...

DURAVENT

FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948007411·DURAVENT UNI XL 1 IC + 1 ICU, SIZE 11

VEO Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996188036·VEO,BULLETED TRIAL,12 DEG,22X11

APEX PS Knee

FDA UDI
Omni Life Science, Inc.·00841690113508·PS-C Insert, Size 2 x 11mm

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383505994·Gutta Percha Points is used to root canal filin...

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973325·

HLS UNI EVOLUTION PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

CRUISER 18 GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 13, 2011

S8 ELITE- AMERICAS

FDA Adverse Event
Malfunction ·Product code BZD·August 15, 2008

PINNACLE MTL INS NEUT36IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 8, 2013

PINNACLE MTL INS NEUT36IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 8, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013

FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM

FDA Adverse Event
Malfunction ·STRYKER GMBH·Product code HSB·March 3, 2025

ARTICULEZE M HEAD 36MM +5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013

REPLICA LG STAT LNG LT 16.5MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 9, 2013

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026