102 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.

STA-SET I.V. FLOW REGULATOR

FDA 510(k)
FDA Class 2 ·General Hospital

Cross-Linked PE Insert

FDA UDI
ADLER ORTHO SPA·08050507130313·Cross-Linked PE Insert 15° Lipped Diam. 36 Gr. C

Trimline

FDA UDI
ORMCO CORPORATION·00889989052107·LOWER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 6

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199946·Steinman Pin No-Drive (152mm), Non Sterile

Arthrex®

FDA UDI
ARTHREX, INC.·00888867385665·Countersink, 2.0mm

AmCAD-UT Detection 2.2

FDA 510(k)
FDA Class 2 ·Radiology

AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE

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

NexGen®

FDA UDI
Zimmer, Inc.·00889024199071·

NexGen®

FDA UDI
Zimmer, Inc.·00889024199064·

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM

HELICAL BLADE INSERTER

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code LXH·June 18, 2014

GOBED II

FDA Adverse Event
Other ·STRYKER MEDICAL QUEBEC LP·Product code FNL·October 19, 2010

ARMADA 14 PTA CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LIT·December 19, 2012

NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTENSION

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KRO·August 26, 2016

NEXGEN ROTATING HINGE KNEE OPTION FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KRO·August 26, 2016

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REGENCY, SENSOLOG III, AND DIALOG II PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG (R) ALTERNATE PRODUCT TRAY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG (R) MODEL 3038 SOFTWARE MODIFICATION