15 results
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19ms
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Sources: EU EUDAMED, US FDA
CONICAL TIPPED CENTRIFUGE TUBE 15M
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Synergy
FDA UDI
Rmo, Inc.·00885797100863·MESIO SY 185 W/O HK 5-5 20EA
VERIFY
FDA UDI
STERIS CORPORATION·10724995021389·The VERIFY Flash Integrator and Patient Record ...
RTI Allograft Paste
FDA UDI
Rti Surgical, Inc.·00898623002095·Allograft Paste IC 10cc
ACUMED
FDA UDI
Acumed LLC·10806378091001·5.5mm PEEK SA Tap
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197494342·Micro Scissors
straig...
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 6, 2007
ORTHO VISION
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·October 23, 2018
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