11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FairFix Adjustable Button System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970126·
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
FDA 510(k)
FDA Class 2
·Microbiology
VIRTUOSAPH PLUS, WITH RADIAL
FDA Adverse Event
Injury
·TERUMO CARDIOVASCULAR SYSTEM CORPORATION·Product code GEI·December 30, 2021
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·JABIL·Product code MLR·October 17, 2008
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
TOTAL ASR FEM IMP SIZE 59
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·July 2, 2013
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 8, 2020
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