14 results · 19ms · Sources: EU EUDAMED, US FDA

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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