19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO TRIATHLON TS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Channel Drain
FDA UDI
C. R. Bard, Inc.·00801741049835·Channel Drain, 10Fr. Round 3/4 Fluted with 3.2m...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021726·
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code GCY·September 15, 2025
CLOSED WOUND SUCTION
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GCY·September 17, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 15, 2025
2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 23, 2013
IMMULITE 2000
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 28, 2011
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·June 17, 2025
SILICONE CHANNEL DRAIN WITH 1/8 IN. TROCAR, 10 FR., ROUND, 3/4 FLUTED
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·July 21, 2017
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 19, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 13, 2025
CLOSED WOUND SUCTION
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GCY·September 17, 2025
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