13 results
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25ms
·
Sources: EU EUDAMED, US FDA
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664806671·Reusable SpO2 Sensor/Masimo/Ear clip/Adult/1.1M...
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ALPHAXENON LIGHT 180 W AND 300 W
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 30, 2014
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWY·November 17, 2010
EXETER CONTEMPORARY RIM CUTTER
FDA Adverse Event
Malfunction
·STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI·Product code JDI·November 30, 2012
Escherichia coli Polyvalent 3 Types O86(B7), O114:K90, O125(B15), O127(B8), O128
FDA UDI
REMEL EUROPE LIMITED·05056080501857·
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024