12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEROYAL SURGICAL, UMBILICUP
FDA 510(k)
FDA Class 2
·Hematology
Safco DENTA-SAFE DENTAL DAM
FDA UDI
SAFCO DENTAL SUPPLY CO.·20810063750194·Medium (0.18mm-0.23mm thickness) 5" x 5", green...
SPARTAN A-10
FDA 510(k)
FDA Class 2
·Dental
CORDIS 13F CATHETER SHEATH INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIU·June 3, 2020
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIU·June 3, 2020
2.4MM STARDRIVE SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HXX·March 26, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 16, 2011
IV ADMINISTRATION SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·March 17, 2008
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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