21 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
FDA 510(k)
FDA Class 2
·Physical Medicine
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390852401·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089436033·
FIDUCIAL MARKERS
FDA 510(k)
FDA Class 2
·Radiology
METHADONE MICROPLATE EIA URINE APPLICATION
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TI TITAMAX EX IMPLANT (4.1)3.75X9
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017
HIP BALL BIOLOX 32 +1 12/14
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·August 14, 2023
HIP BALL BIOLOX 32 +1 12/14
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·February 17, 2023
2520274-2013-02513
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 2, 2011
CAPSURE EPICARDIAL LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code DTB·December 8, 2025
CAPSURE EPICARDIAL LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code DTB·December 8, 2025
HIP BALL BIOLOX 32 +1 12/14
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·February 13, 2023
HIP BALL BIOLOX 32 +1 12/14
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·May 23, 2024
TRI-LOCK BPS SZ 5 HI OFFSET
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2023
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
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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