28 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

RENASYS GO

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Simpact Tri-Fin

FDA UDI
Life Spine, Inc.·00190837063023·Parallel Pin Offset Guide, Small Screw

Trial Liners (Neutral and 10 degree hooded)

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038496·

ADVIA IMS GLUCOSE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

REALSEAL XT SEALER

FDA 510(k)
FDA Class 2 ·Dental

T:SLIM G4 SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code OYC·February 13, 2018

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HRS·June 29, 2018

URETEX SUP URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·May 29, 2013

COLLEAGUE PRE 1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 23, 2016

GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC.·Product code PZE·December 2, 2021

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 48MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 6, 2015

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015