11 results · 29ms · Sources: EU EUDAMED, US FDA

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DOPPLER GUIDED PROCTOSCOPE, MODEL 500H

FDA 510(k)
FDA Class 2 ·Radiology

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809849400·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE MEDIUM-L...

SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 11, 2021

CLINCARE LATEX SURGEON'S GLOVE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

RADIANALYZER, MODEL 12710

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUIK-COMBO PACING/DEFIBRILLATION/ECG

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998

M2A-MAGNUM MODULAR HEAD SZ 52MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 11, 2013

TERUMO CDI 540 CALIBRATOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 1, 2011

PLUM A+ PUMP MEDNET WIRELESS

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code FRN·May 21, 2008

ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·January 7, 2015

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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