20 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
FDA 510(k)
FDA Class 2
·Neurology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120321151·Diamond, cylinder round, COOL DIAMANT, medium grit
OPTIMUM
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975066893·Optimum® HP Carbide Bur Round #4 Pack of 10
Omnicurve
FDA UDI
STRYKER CORPORATION·07613327554496·11G 15mm Fracture Kit
STRYKER 11G 15MM FRACTURE KIT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS·Product code HRX·June 7, 2024
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
SERIM BLOOD LEAK TEST STRIP-2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Delta Wire
FDA UDI
COOK INCORPORATED·00827002188822·Delta Wire, Grasper
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
NForce
FDA UDI
COOK INCORPORATED·00827002179400·NForce, Nitinol Helical Stone Extractor
NForce
FDA UDI
COOK INCORPORATED·00827002179417·NForce, Nitinol Helical Stone Extractor
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·March 28, 2011
BIOCOR/EPIC MITRAL SUPRA SIZER SET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code DWS·April 18, 2008
EVOLUT PRO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 27, 2020
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 27, 2020
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 26, 2025
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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