14 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310215603·FG Diamond 858-012 needle coarse 5/pack
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120215601·Carbide, torpedo, finishing bur
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450273081·
TRUBYTE DENTURE BASE RESIN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ODONTOSURGE 3
FDA 510(k)
FDA Class 2
·Dental
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 22, 2025
RENAISSANCE 26 P-WASS 10/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 26, 2013
UNKNOWN TSL
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·March 8, 2011
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·March 24, 2008
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·August 22, 2018
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LCP·June 6, 2018
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
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