19 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTERIALFLOW SYSTEM, MODEL 32A
FDA 510(k)
FDA Class 2
·Cardiovascular
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751880·Sterile Single Use Burs - ISO Code 881-012C
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50240191·Rotary instrument für surgical application
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252024019·ANODYNE CERVICAL SCREW - VARIABLE SELF TAPPING...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310240190·Talar Osteotmy Guide, 24mm x 19mm
NEUROTECH MEDISTIM PLUS, TYPE 291
FDA 510(k)
FDA Class 2
·Physical Medicine
ANA EIA DIAGNOSTIC TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 5, 2024
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·March 27, 2013
NI
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MNI·March 14, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
BD¿ 5ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 15, 2017
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 16, 2025
BD¿ 5ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 28, 2017
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·April 16, 2025
5 ML BD DISCARDIT II¿ SYRINGE W/NEEDLE 24G X 1 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 13, 2017
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018