17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIPHERALLY INSERTED CENTRAL CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC-NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004
Endo-Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964015722·Endo Carry-on Procedur Kit contains all of the ...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496001874·MAGIC 70, SIZE ML, FUMO, GRADUATED COMPRESSION ...
COSMED QUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013
FLO-GARD IV. SOLUTION ADMIN.SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·February 25, 2011
SENSOR MEDICS
FDA Adverse Event
CARDINAL HEALTH·Product code LSZ·January 28, 2008
UNO URO/ISC
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code GBM·September 30, 2022
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024