12 results
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19ms
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Sources: EU EUDAMED, US FDA
WIRECLIP TORQUER
FDA 510(k)
FDA Class 2
·Cardiovascular
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828115476·GEN4 INTERACTIVE
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828107303·GEN4 Direct Access
Olympus
FDA UDI
Gyrus ACMI, LLC·00821925046610·nCare 4K Keyboard, All-in-one, Compact, Medical...
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
FDA 510(k)
FDA Class 2
·Hematology
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
DISTRACTOR TIP FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·February 28, 2013
PRESTIGE CERVICAL DISC SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code MJO·March 1, 2011
STERRAD 200 STERILIZATION SYSTEM
FDA Adverse Event
Malfunction
·YAMATO LAB-TECH CO. LTD·Product code MLR·February 21, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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