21 results
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25ms
·
Sources: EU EUDAMED, US FDA
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
FDA 510(k)
FDA Class 1
·General Hospital
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PREMIUM PLUS CEEA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018
MULTI-LINK CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·March 26, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 17, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·March 31, 2008
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code PDJ·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024