12 results · 28ms · Sources: EU EUDAMED, 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