16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613118709·Reusable Blue Bipolar Cord, Angled Instrument E...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0110130·Sounder, Ball Tip, Straight, Soft, Titanium
Navagio
FDA UDI
Kalitec Direct LLC·B073DRK0100330·Assembly, Navagio Fixed Draw Rod, Large Knob
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AGILITY STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PLASTIPAK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 29, 2021
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 10, 2025
VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code MQP·February 20, 2013
VASO VIEW HEMOPRO
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR LLC·Product code GEI·March 11, 2013
RADIAL JAW 4 BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·March 8, 2011
ZEPHYR XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018