15 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040054823·Polycarbonate Crowns
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ORG-9200A
FDA 510(k)
FDA Class 2
·Cardiovascular
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
NEEDLE SFTYGLD 25X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·March 13, 2020
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 29, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 13, 2013
COBAS INTEGRA 800
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code DAP·February 28, 2011
LIGHTSHEER
FDA Adverse Event
Other
·RH-USA, INC.·Product code GEX·February 8, 2008
BD SAFETYGLIDE¿ NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 30, 2018
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
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