16 results
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20ms
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Sources: EU EUDAMED, US FDA
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
FDA 510(k)
FDA Class 2
·Neurology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844498·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE ...
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124665·Modular Offset Stem 9mm x 100mm x 4mm
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
FDA 510(k)
FDA Class 2
·Hematology
WILLI GELLER CREATION AND LF PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
FDA Recall
Terminated
·Hospira Inc·Product code FRN·August 11, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 1, 2013
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 13, 2011
MICROSTAAR INJECTOR CARTRIDGE
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code KYB·May 22, 2008
CryoValve, Pulmonary Valve & Conduit
FDA Recall
Terminated
·Cryolife Inc·Product code MIE·January 16, 2004
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018