20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEPUY STTUNE (TM) PS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Smith & Nephew, Inc.·03596010038883·DISPOSABLE ACETABULUM CEMENT
...
ARGENCO 883KF
FDA UDI
ARGEN CORPORATION, THE·D818111433·Gold based noble metal
Orthoquest
FDA UDI
Young Innovations, Inc.·00843471156254·Cutanium 27° D-Form 016X025
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032644·microSelectron Coupling Transfer Tube (13)
DEPUY ATTUNE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BALLERT CRANIAL MOLDING HELMET
FDA 510(k)
FDA Class 2
·Neurology
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 6, 2022
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD SUZHOU·Product code FOZ·August 16, 2022
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·April 23, 2013
BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·September 23, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011
BD INTIMA II PLUS¿ IV CATHETER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 20, 2022
BD INTIMA II PLUS¿ IV CATHETER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 20, 2022
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·October 6, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
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