20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MicroPen EVO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
24PW - Hanta Virus
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113790·AIR INJECT CANNULA 27GA 22MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 1, 2023
VOLUME VENTILATOR
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT IRELAND·Product code CBK·October 17, 2008
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
BD PLASTIPAK 50ML LUER LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 14, 2023
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 25, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·August 5, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 1, 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