14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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