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

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PROFEMUR HIP SYSTEM MODULAR NECKS

FDA 510(k)
FDA Class 2 ·Orthopedic

Bur PM2-70 80K Diam Ø3.5x80 St

FDA UDI
Bien-Air Surgery SA·17630055514858·

KNIFE HANDLE

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049918·KNIFE HANDLE #3L

BIO-KINETIX® THERMAL NITANIUM®ARCHWIRES

FDA UDI
Ortho Organizers, Inc.·00190707058524·.018 X .025 Upper Bio-Kinetix® Thermal Nitanium...

Monoblock Tibial Trial UC Insert

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043544·

UA Healing Cap

FDA UDI
BICON, LLC·00813110026965·UA6 SP-TP Healing Caps (3)

TEMP-A-SURE

FDA 510(k)
FDA Class 2 ·General Hospital

DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1

FDA 510(k)
FDA Class 2 ·General Hospital

Widex

FDA UDI
Widex A/S·05706069727920·Widex EVOKE E-FA (Autumn Beige S-110 ) Telecoil...

Widex

FDA UDI
Widex A/S·05706069727524·Widex EVOKE E-FM (Autumn Beige S-110 ) RC coil

Widex

FDA UDI
Widex A/S·05706069729924·Widex EVOKE E-FP (Autumn Beige S-110 ) Telecoil...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2024

GMK FIXED CEMENTED TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·November 22, 2013

CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

FDA Adverse Event
Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code HWC·September 29, 2022

PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

FDA Adverse Event
Injury ·ELLIPSE TECHNOLOGIES, INCORPORATED·Product code HSB·May 8, 2013

S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER

FDA Adverse Event
Injury ·CONVATEC.·Product code EXE·September 12, 2014

D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 13, 2011

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·October 31, 2005

Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·May 12, 2021