12 results · 39ms · Sources: EU EUDAMED, US FDA

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Confirm Rx Insertable Cardiac Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

NA

FDA UDI
Synthes GmbH·10886982145130·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

OSE

FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042123755·CLEAR DOUBLE ENDED OCCLUSAL RETRACTOR- SHORT

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

NICHOLS ADVANTAGE THYROGLOB

FDA 510(k)
FDA Class 2 ·Immunology

ACUBEAM, SUPER NOVA, DIO

FDA 510(k)
FDA Class 2 ·Physical Medicine

TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·October 26, 2006

BD PARADIGM LINK GLUCOSE MONITOR

FDA Adverse Event
Other ·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 17, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 2, 2013

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