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

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LASIK EYE DRAPE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HARMONIC ACE 36 CM

FDA Adverse Event
Injury ·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005

VARICES INJECTION NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

FDA 510(k)
FDA Class 2 ·Hematology

XMAX MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·March 7, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

VITALITY DS VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

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

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021