12 results · 27ms · Sources: EU EUDAMED, US FDA

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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