12 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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STRONG Dental Handpieces
FDA 510(k)
FDA Class 1
·Dental
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
REGIUS UNITEA
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 17, 2024
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606152129·17 X 14 CERVICAL TRIALS 36MM 10° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151931·17 X 14 CERVICAL TRIALS 36MM 0° LORDOSIS
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Malfunction
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·December 2, 2007
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021