13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DVT-4000S
FDA 510(k)
FDA Class 2
·Cardiovascular
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551066973·Suction Tube, angular, Ø 1.7 mm
UP - Vehicle - 380-55230 - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133319·LATERAL,INNER SLEEVE
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SURETAC III, MODELS 7209900, 7209901
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
OMNI-FLOW MODEL 4000 PLUS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 15, 2008
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 11, 2011
CRUTCH
FDA Adverse Event
JAN MAO·Product code IPR·July 2, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 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