52 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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