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