14 results · 28ms · 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.

Dental Glass Ceramics Blocks

FDA 510(k)
FDA Class 2 ·Dental

Edge™ Diamond FP023-5EF Football Pointed

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003230·Diamond dental bur, reusable

DISCOVERY NM 750B

FDA 510(k)
FDA Class 1 ·Radiology

GEBDI TRIBOS 501

FDA 510(k)
FDA Class 2 ·Dental

TPRLOC COCR CMTD STM T1 12.5MM

FDA Adverse Event
Death ·BIOMET UK LTD.·Product code JDI·March 23, 2026

CMK MOD 12/14 SZ202 L130

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023

URETERAL BRUSH BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FDX·November 15, 2023

CMK MOD 12/14 SZ202 L130

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·January 8, 2026

URETERAL BRUSH BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FDX·January 7, 2022

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012