19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
CEREC Optispray
FDA UDI
SIRONA Dental Systems GmbH·E27662038192·Special nozzle CEREC Optispray 25 pcs.
UltraStick
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850689007572·3" Round Foam, Case of 10
UltraStick - HJ & Associates PL
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237900932·3" Round Foam
UltraStick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007575·3" Round Foam
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·November 5, 2020
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 27, 2024
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
FDA 510(k)
FDA Class 3
·Cardiovascular
FIBERFILL SGP
FDA 510(k)
FDA Class 1
·Dental
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857188396·Parallel Angled Trial, Size 18x50x16 mm
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·October 27, 2025
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 27, 2014
ATTAIN COMMAND
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DQY·August 11, 2011
STRYKER GO BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·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
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