21 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Freedom Peripheral Nerve Stimulator (PNS) System
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113967·HYDRO-DISSECT CANNULA 25GA ANGLED 7MM
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
FDA 510(k)
FDA Class 2
·Orthopedic
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 8, 2025
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 16, 2023
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 16, 2023
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 16, 2023
ADVANIX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 6, 2014
ANGLED LONG SABER ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 22, 2011
NRG KNEE P/S NRG BEARING INSERT SIZE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 18, 2013
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·October 30, 2017
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025
DREAMSTATION2 ADVANCE AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 9, 2023
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 16, 2023
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 4, 2025
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014