21 results · 30ms · Sources: EU EUDAMED, US FDA

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Evie Med Ring

FDA 510(k)
FDA Class 2 ·Cardiovascular

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074494197·CD HORIZON SPIRE - OUTER CASE

MaXcess

FDA UDI
Nuvasive, Inc.·00887517197177·MaXcess 4 Blade, 90mm Left

OsteoMed

FDA UDI
OSTEOMED LLC·00845694022637·FPS 2.0mm Subcondylar Plate

Spud

FDA UDI
KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD

OsteoMed

FDA UDI
OSTEOMED LLC·00845694076845·FPS 2.0 Subcondylar Plate Sterile Qty 2

HDL-EX SEIKEN ASSAY KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

TSV BELLATEK ENCODE HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 5MM (H)

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code NHA·January 4, 2021

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·November 22, 2013

SUMMIT POR TAPER SZ5 STD OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 16, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 16, 2013

PINNACLE SECTOR II CUP 58MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 16, 2013

PINN MAR NEUT 36IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 16, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 21, 2008

REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·August 17, 2011

PRIMEADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·July 22, 2013

PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

Philips Zenition 50, Model Number: 718096

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014