Device Directory
Browse 126 FDA-cleared medical devices
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (K241443)
Class Class II K241443 NUC
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (K241348)
Class Class II K241348 MQK
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (K241454)
Class Class II K241454 MQK
Sonicaid Team3 (K241368)
Class Class II K241368 HGM
VIVACE (K242111)
Class Class II K242111 HGX
0.04 ZERO ZERO FOUR Male Latex Condom (K243584)
Class Class II K243584 HIS
SperSort™ Sperm Sorting Chip (IPG02) (K241626)
Class Class II K241626 MQK
Wearable breast pump (model W8) (K242850)
Class Class II K242850 HGX
AirSurgN Insufflator (10030/AirSurgN) (K242772)
Class Class II K242772 HIF
LapBox Power Tissue Containment System (K250212)
Class Class II K250212 PMU
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