23 results · 21ms · Sources: EU EUDAMED, 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