13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPTURE-R READY INDICATOR RED CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·January 8, 2016
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
CLICKFINE 32GX4MM DONGBAO 7CT
FDA Adverse Event
Injury
·YPSOMED AG·Product code FMI·October 20, 2023
TEMPO
FDA Adverse Event
Malfunction
·ARJO MED. AB LTD.·Product code FNG·November 5, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 3, 2013
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
ORG-9110A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code DRG·September 18, 2025
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 13, 2019
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024