15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHROCARE ARTHROWANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033584·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...
EXCITE SELF ETCH
FDA 510(k)
FDA Class 2
·Dental
NEOLYNX SCREENING APPLICATION MANAGER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 6, 2022
PINN CAN BONE SCREW 6.5MMX35MM
FDA Adverse Event
Injury
·J & J MEDICAL (DEPUY- SUZHOU)LTD. 3006356043·Product code NDJ·April 3, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 11, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·April 23, 2008
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024
TERUMO PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
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 Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024