11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PREG-Q EARLY PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERFORMATRAK
FDA UDI
Respironics, Inc.·00606959000797·PerformaTrak Mask with Standard Elbow, Large, R...
NA
FDA UDI
STRYKER CORPORATION·07613327062069·HTA Scope Bridge for 2.7 mm Hysteroscope
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
FDA 510(k)
FDA Class 2
·Anesthesiology
FOCUS RADIATION TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MAYFIELD ULTRA BASE UNIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·March 21, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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