16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Unscented Tampon
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856694·STRUT 6241064 ANATOMIC 16X14X5MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994304896·STRUT 6241064 ANATOMIC 16X14X5MM
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265231·
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982165633·3.5MM CLAVICLE HOOK PLATE 6 HOLES RIGHT-18MM HO...
2.0/2.4MM FRACTURE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036035990·
Portex
FDA UDI
ICU MEDICAL, INC.·15019517083279·
VESOFLOW PLUS DVT COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOKNOTLESS RC ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 10, 2014
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code LOX·November 20, 2008
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 17, 2011
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
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