13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
Viper Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235315·
ENDER NAIL
FDA UDI
Smith & Nephew, Inc.·03596010104434·3.5MM DIAMETER NAIL 3.5MMX31CM
...
LCP
FDA UDI
Synthes GmbH·10886982157850·3.5MM LCP PLATE 3 HOLES 46MM
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MAXI MOVE
FDA Adverse Event
Malfunction
·BHM MEDICAL INC.·Product code FSA·July 21, 2011
PERMANENT LIFE SUPPORT SET
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTQ·October 29, 2014
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026