28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Extremity Medical Calcaneal Osteotomy Device
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699526·GENUMEDI PSS BLUE, SIZE O
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450292167·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE
Echo® Press-Fit Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260995·
ECHO PRESS-FIT HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304457560·
SunMed
FDA UDI
SUNMED, LLC·20889483002398·WILLIAMS AIRWAY SZ 9cm P/10
FOB ONE STEP RAPID TEST
FDA 510(k)
FDA Class 2
·Hematology
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
FDA 510(k)
FDA Class 2
·Anesthesiology
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 7, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·May 30, 2013
CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 7, 2011
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 20, 2016
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 12, 2016
DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015