11 results
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27ms
·
Sources: EU EUDAMED, US FDA
MODIFIED LABELING OF SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Arthrex®
FDA UDI
ARTHREX, INC.·00888867051492·LO-PRO SCRW,TI,4.0MMX 34MM
MODEM ACCESSORY FOR EPI CARDIA SYS
FDA 510(k)
FDA Class 2
·Cardiovascular
SONOCARE
FDA 510(k)
FDA Class 1
·Dental
CANNULATED DRILL BIT, 4.0MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HTW·June 25, 2014
ARCOM 28MM RNGLOC LINER HIWALL 25
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·January 3, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·November 3, 2010
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014