19 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089473700·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032682·microSelectron Coupling Transfer Tube (16)
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
MOBILE-PATIENT VIEWER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTROCAN SAFETY
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FPA·April 12, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
HYLAMER 10D 58 OR 70ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 13, 2011
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
5.5 EXP VERSE SCR 6.0X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
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