14 results · 21ms · Sources: EU EUDAMED, US FDA

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JET-X HA COATED HALF PINS

FDA 510(k)
FDA Class 2 ·Orthopedic

Safco D1amond

FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751002·Sterile Single Use Burs - ISO Code 605-018C

SunTech

FDA UDI
SUNTECH MEDICAL, INC.·10840935108931·

BD SYRINGE 20ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMF·January 16, 2024

DYRACT CEM LCI COMPOMER

FDA 510(k)
FDA Class 2 ·Dental

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES BETTLACH·Product code HWC·September 23, 2015

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·March 27, 2013

ESPRIT VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·March 18, 2011

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008

APPLIANCE, FIXATION, NAIL

FDA Adverse Event
Injury ·SYNTHES USA·Product code KTT·August 18, 2015

APPLIANCE,FIXATION,NAIL

FDA Adverse Event
Injury ·SYNTHES BETTLACH·Product code KTT·October 10, 2016

PENUMBRA SMART COIL

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·October 26, 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