13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BcSs-PICNI-2000 Sensor
FDA 510(k)
FDA Class 2
·Neurology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026537·Deaver Retractor, #0-1, 1" wide, 10"
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
FDA 510(k)
FDA Class 2
·General Hospital
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·June 17, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
RENAISSANCE 26 P-WASS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 22, 2011
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·November 13, 2018
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code NEW·October 24, 2024
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