13 results · 19ms · Sources: EU EUDAMED, US FDA

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CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A

FDA 510(k)
FDA Class 2 ·Cardiovascular

Premier Composite Instruments

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009750·CPF DE_Gregg 4/5

Implant Prosthetics

FDA UDI
Preat Corporation·00842092133279·Hollow MUA Analog

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575301706·Replacement set, CoCrMo, UHMWPE, rotating hinge...

Diamondback Coronary

FDA UDI
Cardiovascular Systems, Inc.·10852528005800·SALINE INFUSION PUMP (SIP)

LEICA COLPOSCOPE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

ESSURE

FDA Adverse Event
CONCEPTUS INC.·Product code HHS·March 12, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 24, 2011

ARROW HOWES

FDA Adverse Event
Injury ·ARROW INTERNATIONAL·Product code DQO·December 28, 2007

SMARTSET GHV GENTAMICIN 40G

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LOD·March 13, 2019

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