12 results · 20ms · Sources: EU EUDAMED, US FDA

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VOLUSON E6/E8/E8EXPERT/E10

FDA 510(k)
FDA Class 2 ·Radiology

JOBST UltraSheer

FDA UDI
BSN MEDICAL, INC.·00035664223274·ULTRA SHEER 30-40 MM HG THIGH W/DOT BAND CLOSED...

CLEARVISION DR 7000F

FDA 510(k)
FDA Class 2 ·Radiology

NOVUS SPECTRA

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 31, 2023

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

ORTHO SUMMIT SAMPLE HANDLING SYSTEM

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code JTC·June 12, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2011

SENSATION PLUS 8FR. 50CC IAB

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

SENSATION PLUS 7.5FR. 40CC IAB

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

SENSATION 7FR. 34CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014