16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FreeStyle Lite Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II
Leg Bag
FDA UDI
C. R. Bard, Inc.·00801741050800·Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Va...
Oticon
FDA UDI
Oticon A/S·05707131287434·H11V2, MINIRITE 312 WL DBL
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811739·Marina Dissector, 10mm Tapered & Rounded Tip ,S...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332601·IN-OVATION® C Roncone 022 UL/3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332101·IN-OVATION® C Base Rx 022 UL/3-3 CS HK
CLEARCANVAS RIS / PACS
FDA 510(k)
FDA Class 2
·Radiology
SURGI-WRAP MAST BIORESORBABLE SHEET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·May 30, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
PROLIEVE THERMODILITATION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 21, 2008
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024