12 results
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35ms
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Sources: EU EUDAMED, US FDA
BETA-CAP II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776355135·R-Type ball-dissector straight OL 191mm (7 1/2"...
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031377·Rhoton® Dissector, Teardrop, Etched Label #15, ...
ACUMED
FDA UDI
Acumed LLC·10806378050961·Ratcheting COMP PLT Brdge/Leg Removal TL
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130160·
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05
FDA 510(k)
FDA Class 2
·Orthopedic
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code NVY·April 25, 2014
ADVANTAGE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·October 23, 2012
FLEXTOME CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 16, 2010
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