13 results
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19ms
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Sources: EU EUDAMED, US FDA
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