12 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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Flexible Video Cysto-Urethroscope (C-view)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958002441·Medilas D LiteBeam+ Diode Laser, 1470 nm, D-Plug
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
SOLAR SPO2 MODULE WITH MASIMO SET
FDA 510(k)
FDA Class 2
·Cardiovascular
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 27, 2014
SCREW-IN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
COULTER® ACT DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 2, 2013
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·October 24, 2024
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