19 results · 27ms · Sources: EU EUDAMED, US FDA

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VU C*POD INTERVERTEBRAL BODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

Bone cutters

FDA UDI
DFS - DIAMON GmbH·04057176162038·Bone Cutter type 167 HP

THE AUTOTAC SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

EASYRA UREA NITROGEN AND CREATININE REAGENTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CADD SOLIS VIP PUMPS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022

MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code FTL·September 23, 2015

PELVICOL 2CM X 7CM 1.0MM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·April 10, 2013

M3155 RELEASE L.0 UPGRADE

FDA Adverse Event
Death ·PHILIPS HEALTHCARE·Product code MHX·May 27, 2011

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 13, 2008

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022

MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

ZENAPRO HYBRID HERNIA REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH, INC.·Product code FTL·August 8, 2014

¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code FTL·November 30, 2015

PREMILENE 3/0 (2) 75CM DS24 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019

MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

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

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025