15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CervAlign® Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003454·Luna Opal R Mini .018 Kit 5x5 U Hooks 3
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113386·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
BLACKHAWK Cervical Spacer System
FDA UDI
Choice Spine, LP·00840996164443·BLACKHAWK,STERILE,LORDOTIC,14X12X8
MICROGARD II
FDA 510(k)
FDA Class 2
·Anesthesiology
Demetra Analytics Toolkit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
5.0MM X 10FT FIBEROPTIC LIGHTCABLE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY SAN JOSE·Product code FST·August 8, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 8, 2013
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023
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