21 results · 32ms · Sources: EU EUDAMED, 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