13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VersaCross RF Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025033·G95 Mini Incubator
MedDrain
FDA UDI
ARMM INC.·10850082007216·MedDrain 7mm Mediastinal Catheter 4 Eyes - Top
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM
CLAVEGUARD FREEDOM SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Zimmer, Inc.·00889024119680·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 20, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025