15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADULT DUAL-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 19, 2012
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI
Carbide burs
FDA UDI
DFS - DIAMON GmbH·04057176149022·Ortho carbide bur C219-O CA 1,6
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818615·Malleable Retractor 3" x 7" w/ Protective Edge
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321108160·
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742122434·DRACO MetaFuse Plantar Plate, Ti - (L)37mm, R
DENTO-PREP PARTICLE MICROBLASTER
FDA 510(k)
FDA Class 2
·Dental
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·September 23, 2014
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 1, 2011
REVITAN, RASP, DISTAL, CURVED, 14/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 11, 2018
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
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021