Aerin Medical Inc

FDA Filings

This page includes the latest FDA filings for Aerin Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Aerin Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3013497655
FEI Number3013497655
NameMatthew M Hull
Owner & OperatorAerin Medical Inc.
Contact Address232 E. Caribbean Drive
Sunnyvale CA 94089 US
Official Correspondent
  • Matthew M Hull
  • x-916-6423554-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address232 E Caribbean Dr
Sunnyvale, CA 94089 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3011625895
FEI Number3011625895
NameAERIN MEDICAL INC.
Owner & OperatorAerin Medical Inc.
Contact Address232 E. Caribbean Drive
Sunnyvale CA 94089 US
Official Correspondent
  • Matthew M Hull
  • x-916-6423554-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address232 E Caribbean Dr
Sunnyvale, CA 94089 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Aerin Medical Inc.
Reach Needle CAT1614-052024-06-18
Aerin Medical Inc.
VivAer® Stylus CAT17852024-01-15
Aerin Medical Inc.
Power Cord (UK) 15 FT CAT309-062023-10-27
Aerin Medical Inc.
Power Cord (OUS) 15 FT CAT309-042023-10-27
Aerin Medical Inc.
Power Cord (UK) CAT309-032023-10-27
Aerin Medical Inc.
Power Cord (OUS) CAT309-012023-10-27
AERIN MEDICAL INC.
Vivaer ARC Stylus CAT4102023-04-04
AERIN MEDICAL INC.
Foot Switch CAT3072023-04-04
AERIN MEDICAL INC.
Power Cord CAT309-022023-04-04
AERIN MEDICAL INC.
Aerin Console Set CAT305-022023-04-04
AERIN MEDICAL INC.
Aerin Console CAT3052023-04-04
AERIN MEDICAL INC.
InSeca ARC Stylus CAT4092023-04-04
AERIN MEDICAL INC.
RhinAer® Stylus CAT13942022-08-29
Aerin Medical Inc.
RhinAer® Stylus (FG1393)2022-07-29
AERIN MEDICAL INC.
Power Cord 15 ft (US) 309-052021-07-23
AERIN MEDICAL INC.
VivAer® Stylus CAT7232020-10-27
Aerin Medical Inc
VivAer Stylus2020-04-13
AERIN MEDICAL INC.
RhinAer Stylus CAT8212020-02-11
Aerin Medical Inc.
RHIN1 Stylus2019-12-20
AERIN MEDICAL INC.
Sterile Aquasonic 100 Ultrasound Transmission Gel CAT447-Q062019-02-18
Matthew M Hull [Aerin Medical Inc.]
Vivaer Stylus2017-12-12
Matthew M Hull [Aerin Medical Inc.]
Vivaer ARC Stylus2017-12-12
AERIN MEDICAL INC.
Vivaer Stylus2017-12-12
AERIN MEDICAL INC.
Vivaer ARC Stylus2017-12-12
Aerin Medical, Inc.
Vivaer ARC Stylus2017-12-05
Matthew M Hull [Aerin Medical Inc.]
InSeca ARC Stylus2017-11-16
Matthew M Hull [Aerin Medical Inc.]
Aerin Console2017-11-16
AERIN MEDICAL INC.
InSeca ARC Stylus2017-11-16
AERIN MEDICAL INC.
Aerin Console2017-11-16
Aerin Medical, Inc.
InSeca ARC Stylus, Aerin Console2017-01-11
Aerin Medical, Inc.
Aerin Medical Stylus2016-09-22
Aerin Medical, Inc.
Aerin Medical Wand Model FG0112015-11-19

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