12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMIX INSIGHT X-RAY SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
Symmetry Lucae
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482052877·Symmetry® Forceps, Lucae Bayonet Dressing, Regu...
TRAY OF SURGICAL SCREW DRIVERS
FDA Adverse Event
Malfunction
·SHUKLA MEDICAL, INC.·Product code HXX·November 10, 2020
NUMED TYSHAK AND Z-MED PTV CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
BCS SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 24, 2024
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·April 23, 2013
LIFEPAK 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·March 17, 2011
RIATA PASSIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024