12 results
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27ms
·
Sources: EU EUDAMED, US FDA
VIRTUSO SYSTEM FOR IHC (DO-7)
FDA 510(k)
FDA Class 2
·Hematology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016637·Crilewood NH, 6"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045384·PrimaLIF LLIF PEEK Implant, 13mm X 18mm X 50mm,...
RADSCAN EQUIPMENT SLICKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
FDA 510(k)
FDA Class 2
·General Hospital
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 4, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC.·Product code MND·September 19, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 5, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 3, 2017
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024