14 results
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20ms
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Sources: EU EUDAMED, US FDA
OsteoSync Ti Dental Mesh
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776410599·Diamond Cobb Elevator 3/4" Head X 13.75" OL
NA
FDA UDI
DEPUY SPINE, LLC·10705034000770·SPINAL INSTRUMENT DIAMOND HEAD ELEVATOR 19.05mm
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
FDA 510(k)
FDA Class 2
·Immunology
ADAPTERS WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
SJM EPIC STENTED PORCINE HEART VALVE
FDA Adverse Event
Injury
·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
FDA Enforcement
Class II
·Ongoing·Copan Diagnostics Inc·September 27, 2023
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·January 7, 2026
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
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 1, 2015