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

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X-RAY VVA

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII

Working Tube

FDA UDI
ELLIQUENCE, LLC·00846338006358·

T-Crystal cartridges Amhari/Purple Pink

FDA UDI
PERFLEX LTD·07290110506278·5 identical cartridges sealed in a vacuum bag ;...

CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO: COMPEL SURGICAL DRAPES

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

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

AMISTEM H FEMORAL STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·November 13, 2012

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012

ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

FDA Adverse Event
Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

FDA Adverse Event
Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·May 14, 2013

UNKNOWN DEPUY ASR ACETABULAR CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·May 18, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016

Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

FDA Enforcement
Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025