24 results
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37ms
·
Sources: EU EUDAMED, US FDA
ARIA
FDA 510(k)
FDA Class 2
·Cardiovascular
365 by Whole Foods Market
FDA UDI
CORMAN SPA·00099482522919·365 Organic Cotton Tampons without Applicator -...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040062470·Endoflex Reamers 21 mm
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496001317·MAGIC 50, SIZE M, NERO, TIGHTS WITH A THREE-DIM...
Fitbone Trochanteric
FDA UDI
ORTHOFIX SRL·18059015376418·FITBONE TROCHANTERIC TRIAL NAIL L317MM D11MM
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001317·artVeneer life lower anteriors, UCL, C1
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001317·Trial 12mm M 12°
Phonak Brand
FDA UDI
Sonova AG·07613389403053·myPhonak 4.0 app
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
FDA 510(k)
FDA Class 2
·General Hospital
UniTip Catheter
FDA UDI
Unisensor AG·07640172971352·
MINIMED QUICK-SET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·April 10, 2025
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 17, 2021
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 4, 2024
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 14, 2018
HIWIRE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Injury
·COOK, INC.·Product code DQX·March 5, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 24, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 19, 2008
SENSAR IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·May 7, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013