18 results
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35ms
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Sources: EU EUDAMED, US FDA
BONE-DRI SURGICAL SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664807241·Reusable SpO2 Sensor/Masimo/Y-type Multi-site/A...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315809178·XCE 3 red, 4x conc., 125 µl, Centromere-Specifi...
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315808393·XCE 3 orange, 4x conc., 125µl, Centromere-Speci...
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315810150·XCE 3 blue, 4x conc., 125µl, Centromere-Specifi...
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NEURON SELECT CATHETER SIZE 070
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE CDC ANAEROBE 5% SB 100 EA JP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·September 9, 2021
PLATE CDC ANAEROBE 5% SB 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·June 28, 2021
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 9, 2014
NOVAMAX LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP·Product code NBW·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
USS LOW PROFILE FRACTURE CLAMP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·October 21, 2014
PLATE CDC ANAEROBE AGAR 5% SB 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSG·February 17, 2022
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024