15 results
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35ms
·
Sources: EU EUDAMED, US FDA
SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA
FDA 510(k)
FDA Class 2
·Hematology
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001699·VITROS Immunodiagnostic Products Anti-HBs Calib...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136902·
ACUMED
FDA UDI
Acumed LLC·10806378052460·9mm Flexible Reamer
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·May 9, 2014
ADVANTAGE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·October 23, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code LOM·November 27, 2023
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 31, 2024
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·June 19, 2024
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·January 1, 2014
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024