12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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