13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESPIRATION MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Axcent Acrylics
FDA UDI
GARRECO, LLC·D79337601040·ORTHO ACR PDR CLEAR SC (4 OZ EACH)
ILIF
FDA UDI
Nuvasive, Inc.·00887517262868·ILIF Distractor Tube
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022216·ASSY ORTHCM LPBMPR OLFM -10T 18X45 RT
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190806·FEMORAL TRIAL STUD
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471177822·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
Daytona Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981152307·Laminar Hook, 4.0 x 4.25mm
Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
PRISMATIK CLINICAL ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
MITEK ACL IMPLANTS
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·April 18, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 26, 2012
BIOMET INTERLOK FIXED CRUCIATE PLATE 79MM WITH LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 16, 2010
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020