21 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003081·TIBIAL ONLAY ANTERIOR CUT REF GUIDE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021965·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021972·
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981029890·CLOSED LATERAL CONNECTOR, 6.35 X 60MM
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031268·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197028479·Sims gynecological Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197028486·Sims gynecological Scissors
curved...
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALTH-E-CONNECT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Widex
FDA UDI
Widex A/S·05706069633221·Compass V5.9.2 CD-ROM
LEGACY CASSETTE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·October 21, 2021
CASSETTE MEDI RESERVOIR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·October 21, 2021
STRYKER SYSTEM 6
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS,DIV OF STRYKER CORP·Product code GFA·May 16, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JWH·June 7, 2011
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·August 15, 2008
V.A.C. FREEDOM THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015