13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stryker Steri-Shield 8 Surgical Hoods and Togas
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265651·
LCP
FDA UDI
Synthes GmbH·10886982166357·3.5MM LCP® POSTEROLATERAL DSTL HUMERUS PL-LAT S...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022927·FPS 2.7mm Hook Plate, Short
OsteoMed
FDA UDI
OSTEOMED LLC·00845694077422·FPS 2.7 Hook Short Plate Sterile Qty 5
DYRACT CEM PLUS CEMENT
FDA 510(k)
FDA Class 2
·Dental
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CERTAIN® GOLD-TITE® HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 31, 2022
TALENT THORACIC STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIO VASCULAR·Product code MIH·November 21, 2008
HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·August 19, 2011
PFCSIGMA 3POST RDDOME PAT 41MM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.·Product code JWH·July 22, 2013
REBAR
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·March 11, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014