17 results · 21ms · Sources: EU EUDAMED, 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