9 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REUNITE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Aspira Drainage Kit
FDA UDI
Bard Access Systems, Inc.·00801741045035·Aspira Pleural/Peritoneal Drainage Kit
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
FDA 510(k)
FDA Class 1
·General Hospital
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 7, 2013
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
INSYNC III PROTECT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014
a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code DWM·May 25, 2022