10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BACTIRACIN DIAGNOSTIC DISC
FDA 510(k)
FDA Class 1
·Microbiology
PULSE
FDA UDI
Nuvasive, Inc.·00195377065544·PULSE Software, v4.0.0-bln.eu
MODEL 4810 ANALYZER OUTPUT ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 9, 2014
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 18, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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