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