17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BARF BAND
FDA 510(k)
FDA Unclassified
·Unknown
Valencia Skin Applicator
FDA UDI
Nucletron B.V.·08717213032071·Valencia Ft Skin Applicator, Ø 20mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818684·Malleable Retractor 4" x 10" w/Protective Edge
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
FDA 510(k)
FDA Class 2
·Radiology
PREVENA INCISION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCEED MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·September 25, 2018
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·March 4, 2025
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·March 5, 2025
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code GZB·March 5, 2025
ORION RC SCS IPG
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·March 5, 2025
DUR DYNAMIC LOCK RING 60 OR 72
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code LPH·May 14, 2013
VALIANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 23, 2014
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 1, 2011
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019
Absorbable Collagen Sponge Provided As Intermediate to Another Company
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Achieva 1.5T Conversion
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024