19 results · 31ms · Sources: EU EUDAMED, US FDA

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Multi-unit Abutment, Multi-unit Angled Abutment

FDA 510(k)
FDA Class 2 ·Dental

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM

NA

FDA UDI
Stryker GmbH·07613154639984·Screw Marker 38,8

Arena-C®

FDA UDI
SPINEFRONTIER, INC.·00190361021186·Arena-C HA, 11X17 Lordotic, 8mm

TAKE 1

FDA 510(k)
FDA Class 2 ·Dental

IRRIGATION SETS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AGX

FDA UDI
Widex A/S·05706069749816·Audigy AGXWU-IP (Light beige S-440 ) Right

BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·December 15, 2020

BAHA FLANGE FIXTURE AND ABUTMENT

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 27, 2014

SURGIMESH

FDA Adverse Event
Malfunction ·ASPIDE MEDICAL·Product code FTL·June 27, 2013

MAXIMO VR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

BD POSIFLUSH¿ PRE-FILLED SYRINGE

FDA Adverse Event
Malfunction ·Product code FOZ·October 28, 2021

NEEDLE 23G 1IN TW

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·April 14, 2020

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

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025