11 results · 21ms · Sources: EU EUDAMED, 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