21 results · 30ms · Sources: EU EUDAMED, US FDA

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Aequalis Fx2

FDA 510(k)
FDA Class 2 ·Orthopedic

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302758·Femoral Segment

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302796·Femoral Segment

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302802·Femoral Segment

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302833·Femoral Segment

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302734·Femoral Segment

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302840·Femoral Segment

2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC

FDA 510(k)
FDA Class 2 ·General Hospital

CI KNEE, CI MI TKR

FDA 510(k)
FDA Class 2 ·Neurology

SPECTRA

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 8, 2014

MAVERICK2 BALLOON CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 7, 2011

INSYNC SENTRY

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013

ELAN 4 MIS SLEEVE F/1-RING HANDPIECES

FDA Adverse Event
Injury ·AESCULAP AG·Product code HBC·October 28, 2018

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 12, 2016

COBAS INTEGRA 400 CU

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 12, 2016

ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code HBC·November 5, 2018

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 2, 2016

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017