11 results · 21ms · Sources: EU EUDAMED, US FDA

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SORBACT WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

LASER 4SPSC340

FDA 510(k)
FDA Class 2 ·Physical Medicine

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

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

ACIST

FDA Adverse Event
Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 17, 2013

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2011

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

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