21 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Traxcess 7 Mini Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
UP - Vehicle - 380-55230 - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal
HARDYDISK CINOXACIN, 100 MCG
FDA 510(k)
FDA Class 2
·Microbiology
SIMPLICITY EASY ACCESS P INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 21, 2014
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·November 21, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·October 17, 2008
ENTROY
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FNG·June 27, 2013
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 4, 2011
VALVE IN CARTRIDGE, 6MM
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code NJK·November 15, 2023
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 24, 2020
VALVE IN CARTRIDGE, 7MM
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code NJK·November 2, 2022
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 28, 2023
PLATE TSA SB 5% 100MM 10EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSG·October 26, 2022
Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code LRO·August 15, 2007
S.M.A.R.T. NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·March 10, 2014
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025