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

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CSTAT, MODELS 09-0014-01 AND 09-0014-02

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD Impress

FDA UDI
PERFLEX LTD·07290110501952·Thermoplastic pellets softens within dip hot wa...

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120321251·Diamond, cone rounded edge, COOL DIAMANT, mediu...

Flex

FDA UDI
Diversified Products, Inc.·00842894158623·

PINS AND WIRES

FDA 510(k)
FDA Class 2 ·Orthopedic

OPUS MAGNUM ANCHOR & INSERTER

FDA 510(k)
FDA Class 2 ·Orthopedic

ACRYSOF

FDA Adverse Event
Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 7, 2008

ACRYSOF

FDA Adverse Event
Other ·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·February 7, 2008

RADIESSE DERMAL FILLER

FDA Adverse Event
Other ·MERZ AESTHETICS, INC.·Product code LMH·January 4, 2013

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 18, 2014

EXETER V40(TM). RASP HANDLE

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·April 3, 2013

UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 28, 2011

LIGASURE V SEALER/DIVIDER

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 16, 2008

Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·July 16, 2014

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

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018