14 results · 25ms · Sources: EU EUDAMED, US FDA

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TRI-LOCK HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040044476·Curette Gracey DE 11/12

GRADIA®

FDA UDI
Gc America Inc.·14548161073646·GRADIA® DIRECT Unitips: 10 tips 0.16 mL CVD

GRADIA®

FDA UDI
Gc America Inc.·D0470019821·GRADIA® DIRECT Unitips: 10 tips 0.16 mL CVD

STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

A100 AESTHETIC DIODE LASER

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

UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

FDA Adverse Event
Death ·BECTON DICKINSON·Product code FOZ·April 1, 2016

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·March 11, 2013

UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 27, 2011

OT ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·February 21, 2008

Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

FDA Enforcement
Class II ·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024

UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

FDA Adverse Event
Injury ·BECTON DICKINSON·Product code FOZ·March 4, 2016

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

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