24 results · 26ms · 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.

LINK TrabecuLink Femoral Cones

FDA 510(k)
FDA Class 2 ·Orthopedic

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003134·600 micron Holmium Laser Fiber Cable, Single Us...

24PW - Hanta Virus

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White

FAA Airline - 24 Poly White

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013244·FAA Airline - 24 Poly White

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM

MODIFICATION TO ENTEC PLASMA WANDS

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

BD DIRECTIGEN FLU A+B

FDA 510(k)
FDA Class 2 ·Microbiology

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES (USA)·Product code HRS·March 10, 2015

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code LWS·October 9, 2013

COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code KRH·October 14, 2008

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 26, 2013

SYNCHROMED

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·August 3, 2011

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·August 15, 2014

OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·April 12, 2021

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·June 16, 2017

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·June 16, 2017

CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

WIRE, SURGICAL

FDA Adverse Event
Injury ·SYNTHES USA·Product code LRN·April 25, 2017

TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.

FDA Recall
Terminated ·TomoTherapy Incorporated·Product code IYE·February 22, 2008