21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
FDA 510(k)
FDA Class 2
·Neurology
CADD
FDA UDI
ICU MEDICAL, INC.·10610586033803·
CADD
FDA UDI
ICU MEDICAL, INC.·10610586033797·
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CADD
FDA UDI
ICU MEDICAL, INC.·10610586042737·
CADD
FDA UDI
ICU MEDICAL, INC.·10610586044168·
PharmGuard
FDA UDI
ICU MEDICAL, INC.·15019517197112·
PharmGuard
FDA UDI
ICU MEDICAL, INC.·15019517081275·
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 30, 2014
CELL-DYN RUBY ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 15, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 9, 2013
COPE NITINOL MANDRIL WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DXQ·April 15, 2019
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·November 12, 2014
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MEA·September 29, 2014
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023