23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
MAKO SURGICAL CORP.·00848486002848·SHORT SINGLE BARREL DRILL GUIDE
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111201·DD tempMED are pre-colored dental milling blank...
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981216825·Trial, 35mm x 27mm x 18mm, 20 Deg
Flexitron
FDA UDI
Nucletron B.V.·08717213026650·Flexitron Transfer Tube for Metal Needles (14)
3D Printed Interbody System
FDA UDI
Seaspine Orthopedics Corporation·10889981303570·Interbody, 35mm x 27mm x 18mm, 20 Deg, 3D
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981214920·Interbody, 35mm x 27mm x 18mm, 20 Deg
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321118200·
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DENTORIUM CONVERTIBLE ACRYLIC
FDA 510(k)
FDA Class 2
·Dental
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376633206·TL VBR 16 mm CORE HT TRIAL, 18/20 mm
BD NEEDLE ECLIPSE 25X1 RB
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMI·June 1, 2024
BD NEEDLE ECLIPSE 25X1 RB
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMI·June 1, 2024
UNKNOWN DEPUY TIBIAL TRAY
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 14, 2013
BREEZY ULTRA 4
FDA Adverse Event
Injury
·SUNRISE MEDICAL·Product code IOR·November 4, 2008
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008
TRI-STAPLE 2.0
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024
LIBRE 2 SENSOR FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
FDA Enforcement
Class III
·Terminated·Diagnostica Stago, Inc.·September 24, 2014