12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRAPES WITH ABSORBENT REINFORCEMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 10, 2012
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 17, 2008
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·July 2, 2013
ERBE APC 2
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·April 12, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025