Formlabs Inc

FDA Filings

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

FDA Registration(s)
Registration Number3015491441
FEI Number3015491441
NameFORMLABS OHIO, INC
Owner & OperatorFormlabs Inc.
Contact Address35 Medford St
Somerville MA 02143 US
Official Correspondent
  • Sam Murray
  • x-617-3561606-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address27800 Lemoyne Rd
Millbury, OH 43447 US
Establishment TypeManufacture Medical Device



Registration Number3010279788
FEI Number3010279788
NameFormlabs Inc.
Owner & OperatorFormlabs Inc.
Contact Address35 Medford St
Somerville MA 02143 US
Official Correspondent
  • Sam Murray
  • x-617-3561606-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address35 Medford St
Somerville, MA 02143 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Formlabs Inc.
3D Printed Nasopharyngeal Swab2020-03-25
FORMLABS OHIO, INC [Formlabs Inc.]
3D Printed Nasopharyngeal Swab2020-03-25
Formlabs Inc.
Surgical Guide Resin2019-03-19
FORMLABS OHIO, INC [Formlabs Inc.]
Surgical Guide Resin2019-03-19

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092619808Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey(755) CARTONS INTO (21)PALLETS CURE V3 PACKAG ING ASSEMBLY,ROHS INV: BNC2000318 PO:51535 HT S CODE: 8516.79.00755 CTN
202009256560Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey(755) CARTONS INTO (21)PALLETS WASH V3 PACKAGING ASSEMBLY,ROHS PO:50537 BNC2000312 HTS CODE: 8479.89.65755 CTN
202009249059Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey(755) CARTONS INTO (21)PALLETS WASH V3 PACKAGING ASSEMBLY,ROHS PO:50537 BNC2000312 HTS CODE: 8479.89.65755 CTN
2020092212783Yantian,China (Mainland) -> Savannah, Georgia(755) CARTONS INTO (21)PALLETS WASH V3 PACKAGING ASSEMBLY,ROHS PO:50537 BNC2000312 HTS CODE: 8479.89.65755 CTN
2020092115836Yantian,China (Mainland) -> Savannah, Georgia(755) CARTONS INTO (21)PALLETS WASH V3 PACKAGING ASSEMBLY,ROHS PO:50537 BNC2000312 HTS CODE: 8479.89.65755 CTN
2020091938684Yantian,China (Mainland) -> Los Angeles, CaliforniaTOTAL: (440) CARTONS INTO (15)PALLETS FORM 3 RESIN TANK HTS CODE: 8443.99.2050 INV: BNC2000327 PO:51368440 CTN
2020091721357Yantian,China (Mainland) -> Savannah, Georgia(755) CARTONS INTO (21)PALLETS WASH V3 PACKAGING ASSEMBLY,ROHS PO:50537 BNC2000312 HTS CODE: 8479.89.65755 CTN
2020091768243Yantian,China (Mainland) -> Los Angeles, CaliforniaTOTAL: (440) CARTONS INTO (15)PALLETS FORM 3 RESIN TANK HTS CODE: 8443.99.2050 INV: BNC2000327 PO:51368440 CTN

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