20 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DAYTRIPPER DIALYSATE WARMER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160692·Channels Flex 21mm 50.06
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827905·ACHIMED ACHILLES SUPP BLACK II
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717108085·Gutta Percha Points, Taper .02, Size #15-#40, 1...
REUSABLE CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 10, 2021
BD 0.3 ML INSULIN SYRINGE WITH ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·September 29, 2021
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 2, 2020
BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 26, 2021
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 23, 2020
BD SYRINGE 0.3ML 31GA 6MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 15, 2021
BD SYRINGE 0.3ML 31GA 6MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 15, 2021
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·May 31, 2007
CQUR V PATCH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·March 21, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 16, 2011
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 22, 2021
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014