16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOMATOM EMOTION 6 CT SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749023684·FOAM LITE BORDER 5X5CM
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
FDA 510(k)
FDA Class 2
·Dental
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·April 24, 2021
MINICAP
FDA Adverse Event
Death
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 27, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·February 18, 2011
30" TRANSPORT STRETCHER
FDA Adverse Event
STRYKER CORP. MEDICAL DIVISION·Product code FPO·March 28, 2008
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
LOGIC CR FEMORAL POR, RIGHT, SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2019
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018