12 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ActivSight Intraoperative Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113653·SUB-TENONS CANNULA 19GA 25MM
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981197544·Smooth Shank Poly. Screw, 3.5mm x 50mm
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 17, 2014
PF PINS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDW·July 3, 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
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 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