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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PORTRAIT STAND-OFF

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

JMS APHERESIS NEEDLE SET ACCORDION TYPE

FDA 510(k)
FDA Class 2 ·General Hospital

ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE

FDA 510(k)
FDA Class 2 ·Anesthesiology

LOCKING SCREW, FULLY THREADED 4X28 MM

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HWC·January 4, 2007

OASYS BLOCKER

FDA Adverse Event
Injury ·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 27, 2025

MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·April 19, 2013

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 8, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018