14 results
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20ms
·
Sources: EU EUDAMED, US FDA
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONMED
FDA UDI
Conmed Corporation·10845854002438·MICRO OSCILLATOR BLADE, FINE, 10 X 13 X 0.4 MM 20°
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970584·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970591·
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
FDA 510(k)
FDA Class 2
·Ophthalmic
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
FDA 510(k)
FDA Class 2
·Microbiology
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·February 27, 2013
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·February 15, 2011
D-TRON PLUS
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 31, 2008
STERILE FX25REC W/RES
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·August 28, 2023
RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ONU·August 3, 2023
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code GEX·May 30, 2023
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
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026