12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BraveCX
FDA 510(k)
FDA Class 2
·Radiology
ZMS®
FDA UDI
Zimmer, Inc.·00889024039841·
SWIMEX SYSTEMS
FDA registration
SWIMEX SYSTEMS·1 product·🇺🇸 United States
DURALOC
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295106760·DURALOC SCREW-IN TRIAL LINER 28mm ID 54mm OD 10...
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
FDA 510(k)
FDA Class 1
·General Hospital
COPILOT
FDA Adverse Event
ABBOTT·Product code DTL·August 12, 2011
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 4, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 10, 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