16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TITANIUM POWERPORT ISP IMPLANTED PORT
FDA 510(k)
FDA Class 2
·General Hospital
Channel Drain
FDA UDI
C. R. Bard, Inc.·00801741049804·Channel Drain, 10mm Flat Full Fluted with 4.7mm...
LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 24, 2025
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021696·
LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 23, 2025
QUIK-CHECK HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
FDA 510(k)
FDA Class 2
·Immunology
Crescendo Meniscal Insert CR Ultracongruent 12mm Size 5
FDA UDI
AMPLITUDE SAS·03701089524773·
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 11, 2019
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 21, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2024
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 23, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 28, 2011
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·July 10, 2008
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
FDA Enforcement
Class II
·Terminated·Precision Medical, Inc.·November 25, 2015
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