12 results · 21ms · Sources: EU EUDAMED, US FDA

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REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001

FDA 510(k)
FDA Class 2 ·Immunology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496022992·WONDER MODEL 70, SIZE XL, CAMEL, GRADUATED COMP...

DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431

FDA 510(k)
FDA Class 2 ·Physical Medicine

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLMA DVC V11.51 N

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2013

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 24, 2011

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·April 3, 2008

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

Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012