18 results
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28ms
·
Sources: EU EUDAMED, US FDA
REPICCI II UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Illusion™ Univeral Restorative
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310202643·Safco universal restorative C3 syr
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717102622·Mirror Heads #5 FS, SS
Kinesia 360
FDA UDI
Great Lakes Neurotechnologies Inc.·00859584006072·Kinesia 360, Sensor Upper
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Injury
·MATORHTO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·March 25, 2013
LEAD MODEL UNKNOWN
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·March 11, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 27, 2008
ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code MIH·September 26, 2025
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
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