18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STD MED PRIMO PORT POLY
FDA 510(k)
FDA Class 2
·General Hospital
Cordera Hip System Offset Reamer Driver, Enztec
FDA UDI
Conformis, Inc.·00810933031107·Offset Reamer Driver, Enztec
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
AT HOME DRUG TEST, MODEL 9063 T
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
FDA 510(k)
FDA Class 2
·Cardiovascular
Panama™
FDA UDI
FLOSPINE LLC·B1830806450160·Self Tapping Rescue Bicortical Variable Screw, ...
Panama™
FDA UDI
FLOSPINE LLC·B1830806450180·Self Tapping Rescue Bicortical Variable Screw, ...
Panama™
FDA UDI
FLOSPINE LLC·B1830806450140·Self Tapping Rescue Bicortical Variable Screw, ...
Panama™
FDA UDI
FLOSPINE LLC·B1830806450200·Self Tapping Rescue Bicortical Variable Screw, ...
Panama™
FDA UDI
FLOSPINE LLC·B1830806450120·Self Tapping Rescue Bicortical Variable Screw, ...
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 9, 2022
ARES ANTIBIOTIC - IMPREGNATED CATHETER KIT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·April 9, 2013
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·April 26, 2011
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·July 22, 2008
COPELAND THN SHL COCR/HA HUMS3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·August 28, 2025
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 29, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014