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

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Classic

FDA 510(k)
FDA Class 2 ·Dental

J6 ARM FOR HIP WITH QD

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·January 15, 2016

J6 ARM FOR HIP WITH QD

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 28, 2015

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996133395·LATERAL,CONVEX EP SCRAPER,TIP,15DEG

PERMOBIL M300 / M400

FDA 510(k)
FDA Class 2 ·Physical Medicine

BIOLOY

FDA 510(k)
FDA Class 2 ·Dental

RSP INSTRUMENTATION

FDA Adverse Event
Malfunction ·ENCORE MEDICAL, L.P.·Product code HWA·October 17, 2008

ADVISA DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code NVZ·August 11, 2011

INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·July 2, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 23, 2022

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

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