14 results · 35ms · Sources: EU EUDAMED, US FDA

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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