11 results · 26ms · Sources: EU EUDAMED, US FDA

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KERATOME

FDA 510(k)
FDA Class 1 ·Ophthalmic

Map-iT

FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083018474·STR, 10 electrode, MPD-SL, 2-8-2-8-2-8-2-8-2mm ...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111247194·KRISTELLER SPECULUM 80X30MM

ARTHREX TIBIAL GRAFTBOLT

FDA 510(k)
FDA Class 2 ·Orthopedic

PHOSPHORUS REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ADULT BREATHING CIRCUIT DUAL HEATED

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 30, 2014

PROGRAMMING SOFTWARE

FDA Adverse Event
Injury ·CYBERONICS·Product code LYJ·January 9, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA·Product code NIQ·November 20, 2010

dS Breast 7ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

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