52 results · 32ms · Sources: EU EUDAMED, US FDA

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Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)
FDA Class 2 ·Radiology

DJO SURGICAL

FDA UDI
Encore Medical, L.P.·00190446841654·SPECIAL, EMPOWR DUAL MOBILITY LINER TRIAL, SZ 44G

HHM

FDA UDI
Oticon A/S·05707131351364·G500 SC, BTE PP 13 2.4G 105 C090 HHM

CODMAN

FDA UDI
Cerenovus, Inc.·10886704001836·CODMAN SLIM-LINE Aneurysm Clip Straight Blade L...

AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ALYTE Y-MESH GRAFT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TERRA NOVA® MI Access System

FDA UDI
VB Spine LLC·10888857185746·Medium Retractor Distractor, Size 70 mm

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·April 4, 2018

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Malfunction ·ALLERGAN (COSTA RICA)·Product code FTR·July 30, 2019

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 9, 2017

THERAPY¿ ABLATION CATHETER

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code OAD·August 17, 2017

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·October 27, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

12/14 ARTICUL 44MM M SPEC+12

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 2, 2013

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 12, 2020

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 27, 2019

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 14, 2017

M3155 UPGRADE REL N.0

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 13, 2017

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 31, 2017