13 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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ANSPACH OPERATING TABLE SUPPORT/SPINAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001101·VITROS Immunodiagnostic Products Anti-HCV Calib...
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038013261·NUPRO® Prophy Paste, Strawberry Vanilla, Swirl,...
ACUMED
FDA UDI
Acumed LLC·10806378048418·Pelvic Plating Implant Tray, Lid
Symmetry Hardy
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030547·Symmetry® Enucleator, Hardy, Right, 9.25 in
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
FDA 510(k)
FDA Class 1
·Ophthalmic
NMI IC
FDA 510(k)
FDA Class 2
·General Hospital
KONG-C VBR M, Body, 26 mm
FDA UDI
icotec AG·07640164849737·KONG-C VBR M, Body, 26 mm
FORTIFY ASSURA VR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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