40 results · 23ms · Sources: EU EUDAMED, 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