19 results
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26ms
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Sources: EU EUDAMED, US FDA
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