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

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CerroZone Mini

FDA 510(k)
FDA Class 2 ·General Hospital

LCP

FDA UDI
Synthes GmbH·10886982167903·4.5MM LCP® PROXIMAL FEMUR PLATE 2 HOLES/139MM-LEFT

LEONE SPA

FDA UDI
LEONE SPA·08033707061434·BRACKETS 22 T+10 A+5 CEN U/R

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112717·BARRON VACUUM PUNCH 6.5MM

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506074820·FEMORAL/TIBIAL EXTRACTOR; 11MM X 7-3/4"

NA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295122722·FEMORAL/TIBIAL EXTRACTOR 11mm

YIXIN SAFETY SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

ClearPoint Array System (Version 1.2)

FDA 510(k)
FDA Class 2 ·Neurology

TSV¿ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H)

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·August 9, 2021

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

SUMMIT DUOFIX TAP SZ5 STD OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 10, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025