11 results · 22ms · Sources: EU EUDAMED, US FDA

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STA - CONTROL LA 1+2

FDA 510(k)
FDA Class 2 ·Hematology

Millennia Software

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C1MA031010·The Millennia Software system is indicated for:...

SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES

FDA 510(k)
FDA Class 2 ·Microbiology

ACCELERATOR RECIPROCATING CANNULA

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

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 16, 2013

RESTORE RECHARGEABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 30, 2011

GEMSTAR RECHARGEABLE BATTERY PACK

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code FRN·June 13, 2008

REFLECTION CONSTRAINED ACETABULAR LINER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025

Atakr II RF Power Generator, Models 4802 and 4803

FDA Recall
Terminated ·Product code DQY·November 25, 2002

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