24 results · 22ms · Sources: EU EUDAMED, US FDA

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BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

6100 NDGB

FDA UDI
HANS RUDOLPH, INC.·00874750008476·6100 100 LITER NONDIFF GAS BAG

OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES

FDA 510(k)
FDA Class 2 ·Orthopedic

VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

APEX BALLOON CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 14, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011

NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2023

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2023

CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

FDA Enforcement
Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 19, 2022

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

SENSATION PLUS 8FR. 50CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

SENSATION PLUS 7.5FR. 40CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022