11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERNUM SAW
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006861·VITROS Chemistry Products ApoA1 Reagent
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133871·
Posterior Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
FDA 510(k)
FDA Unclassified
·Unknown
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014
EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code MGB·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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