40 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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RANDOX COMPLEMENT C3
FDA 510(k)
FDA Class 2
·Immunology
Preat
FDA UDI
Preat Corporation·00842092169575·ASC NobelBiocare™ Tri-Lobe-compatible NP X 9mm ...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282503222·TeWa CJ-Type 3025 (s): uncoated acupuncture ne...
TEWA
FDA UDI
asia-med GmbH·04251282510541·TeWa CJ-Type 3025 (s): uncoated acupuncture ne...
SureSmile®
FDA UDI
ORAMETRIX, INC.·00856379007207·Arch wire 16round BETA TITANIUM
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004690·
SAV
FDA UDI
Diversified Products, Inc.·00842894155257·
BELLEGLASS HP OPACEOUS DENTIN
FDA 510(k)
FDA Class 2
·Dental
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
FDA 510(k)
FDA Class 1
·Dental
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004690·
EVIS EXERA II COLONOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDF·November 22, 2024
Disposable Sensor
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616005500·Disposable Sensor DP-2211-2 Nellcor
Sensation 7Fr. 34cc IAB (INDIA)
FDA UDI
DATASCOPE CORP.·10607567109732·Sensation 7Fr. 34cc IAB (INDIA)
Sensation 7Fr 34cc IAB with Accessories (Turkey)
FDA UDI
DATASCOPE CORP.·10607567113128·Sensation 7Fr 34cc IAB with Accessories (Turkey)
Sensation 7Fr. 34cc IAB (China)
FDA UDI
DATASCOPE CORP.·10607567109367·Sensation 7Fr. 34cc IAB (China)
Sensation 7FR. 34cc IAB with Accessories, US Only
FDA UDI
DATASCOPE CORP.·10607567109541·Sensation 7FR. 34cc IAB with Accessories, US Only
Sensation 7Fr. 34cc IAB
FDA UDI
DATASCOPE CORP.·10607567106755·Sensation 7Fr. 34cc IAB
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FPA·January 5, 2015
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Recall
Open, Classified
·Datascope Corporation·Product code DSP·July 27, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Enforcement
Class II
·Ongoing·Datascope Corporation·September 2, 2020