14 results · 20ms · Sources: EU EUDAMED, US FDA

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MICROLUX TRANSILLUMINATOR

FDA 510(k)
FDA Class 2 ·Dental

MINITUB MULTI-PURPOSE CASSETTES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA·Product code NTE·November 20, 2010

CONSULT HCG TEST

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

GORE® PROPATEN® VASCULAR GRAFT

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·March 16, 2021

ASR XL TAP SLV ADAP 12/14+2

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 17, 2013

ISERT ASPHERIC INTRAOCULAR LENS

FDA Adverse Event
Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·March 21, 2011

WALLSTENT ENTERAL ENDOPROSTHESIS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC IRELAND, LTD·Product code MQR·June 19, 2008

CONSULT HCG URINE CASSETTE 5001 25T

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019

GORE® PROPATEN® VASCULAR GRAFT

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·May 19, 2021

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·December 29, 2010

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015