14 results
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19ms
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Sources: EU EUDAMED, US FDA
JEJE TEETHER
FDA 510(k)
FDA Class 1
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034017·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252034017·ANODYNE CERVICAL SCREW - FIXED SELF DRILLING -...
InTess L
FDA UDI
Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square
Liberty Anterior Cervical Plate
FDA UDI
VALORUS SPINE LLC·00811771030574·Fixed Screw, Self Drilling, 4.0x17mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310340170·Talar Osteotmy Guide, 34mm x 17mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820340170·Zadik Calcaneal Guide, 34mm x 17°
H-SCRIBE
FDA 510(k)
FDA Class 2
·Cardiovascular
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
FDA 510(k)
FDA Class 2
·Immunology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 30, 2011
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·April 25, 2008
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
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