20 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
FDA 510(k)
FDA Class 2
·Radiology
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446929734·SPECIAL, TAPERFILL BIPOLAR TRIALS, NEUTRAL OFFS...
StarDental Instrument Solutions
FDA UDI
DENTALEZ, INC.·D7022019320·INSTR MG DE GOLDMAN-FOX 4
NA
FDA UDI
Synthes GmbH·20887587028658·2.0MM IMF SCREW SELF-DRILLING 12MM
SYNTHES 6.5 MM CANNULATED SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
TORNIER CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·Orthopedic
QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
FDA 510(k)
FDA Class 1
·Microbiology
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 17, 2020
RESTELLA
FDA Adverse Event
Injury
·AROA BIOSURGERY·Product code FTM·December 4, 2019
RESOLUTE ONYX OTW
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·July 5, 2019
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·October 20, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·July 2, 2013
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 21, 2020
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·January 2, 2020
UNK - CONSTRUCTS: LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 15, 2026
HEARTWARE VENTRICULAR ASSIST SYSTEM-OUTFLOW GRAFT
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·June 13, 2019
HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·June 26, 2019
CHAIT PERCUTANEOUS CECOSTOMY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KNT·April 17, 2023
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