11 results · 29ms · Sources: EU EUDAMED, US FDA

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STATNET, MODEL 3100

FDA 510(k)
FDA Class 2 ·Neurology

PORTA SMK 82, MODEL 2032

FDA 510(k)
FDA Class 2 ·Dental

XPS NITRO SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

RAD-8

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·July 15, 2015

KYPHX® HV-R? BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014

KYPHX® HV-R? BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014

UNSPECIFIED SAFESET TRANSPAC SETS

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

HEMOCHRON JR. SIGNATURE PLUS SYSTEM

FDA Adverse Event
Injury ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·May 11, 2011

UV FLASH TRANSFER SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 3, 2013

ARDIS PEEK IMPLANT 09X09X22

FDA Adverse Event
Malfunction ·ZIMMER SPINE·Product code MAX·August 20, 2014

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