14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDLINE EPIDURAL AND SPINAL NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165965·Integra® Jarit® Knife Handle, # 3KS, Hexagonal ...
COMFOR-CLINER
FDA 510(k)
FDA Class 1
·Physical Medicine
OPTICAL INTEGRITY LASERGUARD FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 4, 2022
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013
ANGLED ACET INSERTR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·September 23, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 19, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 11, 2016
Achieva 1.5T Conversion
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
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