12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD MALE EXTERNAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
SALTER LABS·00607411301995·Nasal Cannula (Adult) Salter Style® with 1’ (1,...
LEONE SPA
FDA UDI
LEONE SPA·08033707062349·TUBE MIM 22/45 OCC LEFT
LEONE SPA
FDA UDI
LEONE SPA·08033707056454·DB TUBE MIM 22/45 OCC LEFT
Aqueduct 200 Cervical Dilation Balloon Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MOORVMS-PRES PRESSURE CUFF CONTROLLER
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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