16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
FDA 510(k)
FDA Class 2
·Anesthesiology
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206739·5" CHROMATOGRAPHY COLUMN
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206722·5" CHROMATOGRAPHY COLUMN
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206715·5" CHROM COLUMN FINE FILTER
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
TWILITE, TWILITE WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZL·September 6, 2017
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·April 29, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 10, 2011
SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·July 28, 2008
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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