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

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HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED

FDA 510(k)
FDA Class 2 ·Anesthesiology

Conformis Hip System

FDA UDI
Conformis, Inc.·00810933030124·REAMER, ACETABULAR, 57MM FULL

LOCATOR R-Tx

FDA UDI
Zest Anchors, LLC·00840481113499·LOCATOR R-Tx Abutment for 3.8mm Conelog Connect...

SPIFE CHOLESTEROL PROFILE KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

FDA 510(k)
FDA Class 2 ·Immunology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·March 30, 2023

NEOPUFF INFANT RESUSCITATOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·April 20, 2011

ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL COMPANY·Product code MTA·April 26, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 29, 2014

ENDURANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 22, 2011

BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·June 8, 2023

Misys Commercial Laboratory, Laboratory Information System, version 3.4.1

FDA Recall
Terminated ·Misys Healthcare Systems·March 24, 2003

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