17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GPC Intraheal Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
XLP - Toyota - Black - XLPouch
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030111·XLP - Toyota - Black - XLPouch
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361021216·Arena-C HA, 11X17 Lordotic, 11mm
PEN NDL 31GA 5MM 14BAG 700CAS JP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 22, 2021
CRYOCARE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO VIABAHN ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGX
FDA UDI
Widex A/S·05706069749847·Audigy AGXWU-IP (Clay brown S-330 ) Right
PEN NDL 31GA 5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 2, 2021
PEN NDL 31GA 5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 24, 2021
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 7, 2019
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014
CARELINK
FDA Adverse Event
Malfunction
·PLEXUS MANUFACTURING SDN. BHD.·Product code DSI·August 11, 2011
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 3, 2013
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 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