14 results
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35ms
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Sources: EU EUDAMED, US FDA
THE EQUALIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038013281·NUPRO® Prophy Paste, Strawberry Vanilla Swirl, ...
ACUMED
FDA UDI
Acumed LLC·10806378048432·Pelvic Plating Pelvic Ring Platter
Symmetry Hardy
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030554·Symmetry® Enucleator, Hardy Fork, 3-Prong, Bayo...
INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PATHWAY PV ATHERECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
KONG-C VBR M, Body, 28 mm
FDA UDI
icotec AG·07640164849744·KONG-C VBR M, Body, 28 mm
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 8, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 21, 2023
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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