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