12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMC INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819377·Fenestrated Rectal Blade, 7cm, angled
BLUE SKY BIO DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PRONTOSAN ANTIMICROBIAL WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 21, 2016
UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code GEI·February 17, 2021
PENTA
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 23, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 2, 2011
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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