15 results · 28ms · Sources: EU EUDAMED, 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