19 results · 26ms · Sources: EU EUDAMED, US FDA

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B1P ADHESIVE

FDA 510(k)
FDA Class 2 ·Dental

NA

FDA UDI
Smith & Nephew, Inc.·03596010038869·DISPOSABLE ACETABULUM CEMENT ...

MAXCUT CARBIDE BUR (10/pk) FG 1157

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114311·MAXCUT CARBIDE BUR (10/pk) Shape: Straight Dome...

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089431144·

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213032620·microSelectron Coupling Transfer Tube (11)

Orthoquest

FDA UDI
Young Innovations, Inc.·00843471156247·Cutanium 27° D-Form 014X025

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089466245·

ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS

FDA 510(k)
FDA Class 2 ·Cardiovascular

RESIN CEM

FDA 510(k)
FDA Class 2 ·Dental

INTROCAN SAFETY

FDA Adverse Event
Malfunction ·B. BRAUN MELSUNGEN AG·Product code FOZ·April 30, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·September 23, 2014

TOTAL HIP BALL 28MM +11

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·May 13, 2011

HAART 200 AORTIC ANNULOPLASTY RING

FDA Adverse Event
Injury ·CORCYM INC.·Product code KRH·May 8, 2025

HAART 200 AORTIC ANNULOPLASTY RING

FDA Adverse Event
Injury ·CORCYM INC.·Product code KRH·May 9, 2025

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NPT·December 2, 2025

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·November 18, 2021

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

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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