18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AposTherapy System
FDA 510(k)
FDA Class 1
·Physical Medicine
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18032568866032·GOTFRIED PC.C.P. NECK SCREW - 90 MM
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513059·
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100950·DESMARRES LID RETRACTOR #0
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM46001822060901·Rotary instrument for endodontic application
Percutaneous Compression Plate (PC.C.P)
FDA UDI
ORTHOFIX SRL·18033509850530·GOTFRIED PC.C.P. NECK SCREW - 90 MM STERILE
9131 DEFIBRILLATION ELECTRODES
FDA 510(k)
FDA Class 3
·Cardiovascular
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DRC·April 5, 2019
BROCKENBROUGH NEEDLE
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code DRC·March 27, 2019
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 21, 2013
HEARTSTART MRX EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 4, 2014
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·June 23, 2011
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 5, 2019
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 5, 2019
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·April 2, 2019
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
FDA Enforcement
Class II
·Terminated·Kimberly-Clark Corporation·December 25, 2013