10 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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INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
FDA 510(k)
FDA Class 1
·Microbiology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120243601·Carbide, round, bone cutter, A-cut, low vibration
ABR-2000
FDA 510(k)
FDA Class 2
·Neurology
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
FDA 510(k)
FDA Class 2
·Radiology
ENDURANT II ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 27, 2013
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·March 18, 2011
ACCLAIM ELBOW PIN ASSEMBLY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDC·April 2, 2008
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. 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