21 results · 30ms · 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.

PCT System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ceramic Liner Inserter Impactor Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039349·

DUREPAIR DURA REGENERATION MATRIX

FDA 510(k)
FDA Class 2 ·Neurology

CRUISER 18 GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORS-300N SOLUTION WARMER DRAPE

FDA Adverse Event
Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·August 2, 2016

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·June 3, 2019

ATTAIN ABILITY

FDA Adverse Event
Injury ·MPRI·Product code OJX·June 7, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011

VERSACARE

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

NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HAW·April 19, 2017

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·July 24, 2019

TIBIAL INSERT FB SZ 3 RT 10MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·April 13, 2023

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

VANTAGE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014