13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DeepCatch
FDA 510(k)
FDA Class 2
·Radiology
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235568·
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105510·GLOBAL C.A.P. CTA CTA HEAD TRIAL 56 x 21
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105527·GLOBAL C.A.P. CTA CUTTING BLOCK SIZE 56
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105503·GLOBAL C.A.P. CTA CTA HEAD TRIAL 56 x 18
FLU OIA A/B TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
MORTARA SURVEYOR PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
JUVEDERM VOLUMA XC 27G 2X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·October 29, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·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