Strain AI (SAI001)
Exo, Inc.
EXOMOTION LLC. dba Thomashilfen
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004471985 | 3004471985 | EXOMOTION LLC. dba Thomashilfen | 1 | Y | 2026-01-01 | 14221 29th St E # 1 Sumner WA US 98390 |
| 3013718526 | 3013718526 | EXOCAD AMERICA, INC. | 1 | Y | 2026-01-01 | 301 Edgewater Pl Ste 330 Wakefield MA US 01880 |
| 3015200653 | 3015200653 | EXOTOE LLC | 1 | N | 2026-01-01 | 520 Elliot St Charlotte NC US 28202 |
| 3017487805 | 3017487805 | Exo Imaging, Inc. | 1 | N | 2026-01-01 | 4201 Burton Drive Santa Clara CA US 95054 |
| 3018608708 | 3018608708 | EXOKINETICS, INC. | 1 | N | 2026-01-01 | 19 Hagerty Blvd. Unit 15 West Chester PA US 19382 |
| 3021071765 | 3021071765 | EXODUS INNOVATIONS | 1 | N | 2026-01-01 | 1 Exodus Road Sufa Southern IL 85457 |
| 3025468177 | 3025468177 | EXOATLET | 1 | Y | 2026-01-01 | 19700 S. Vermont Avenue, Suite 200 Torrance CA US 90502 |
| 3027475369 | 3027475369 | EXOSYSTEMS INC. | 1 | N | 2026-01-01 | Room# 803, A-dong 43, Changeop-ro, Sujeong-gu Seongnam-si, Gyeonggi-do KR 13449 |
| 3042158827 | 3042158827 | EXOCUBE BIYOTEKNOLOJI ANONIM SIRKETI | 1 | N | 2026-01-01 | MERKEZ MAH. CENDERE CAD. BABPLAZA NO: 30, IC KAPI NO: 20, KAGITHANE, ISTANBUL TR 34403 |
| 3009353261 | 3009353261 | EXODUS VISION, LLC | 1 | Y | 2020-04-25 | 2580 Anthem Village Dr Henderson NV US 89052 |
| 3014117148 | 3014117148 | EXOSKELETAL TECHNOLOGIES LLC. , DBA. EXOGEAR | 1 | N | 2020-04-25 | 140 School st. Kenmore NY US 14217 |
| 3015496050 | 3015496050 | EXOCARE INC. | 1 | Y | 2020-04-25 | 11884 East Ida Circle Englewood CO US 80111 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 305373 | 1245462776 | K242359 | Strain AI (SAI001) | QIH | 2024-11-20 |
| 305373 | 1810823854 | K240953 | AI Platform 2.0 (AIP002) | QIH | 2024-08-05 |
| 305373 | 1127251526 | K232501 | AI Platform (AIP001) | QIH | 2023-11-17 |
| 305373 | 1788209203 | K230497 | Bladder AI (AIBV01) | QIH | 2023-06-22 |
| 305373 | 1730165500 | K222198 | Exo Iris (El2001) | IYN | 2022-11-09 |
| 209813 | 1791132668 | K193352 | AbutmentCAD | PNP | 2021-07-21 |
| 298212 | 1137468892 | K192731 | ZIDA Wearable Neuromodulation System | NAM | 2021-03-19 |
| 209813 | 1420221541 | K183458 | exoplan 2.3 | LLZ | 2019-08-06 |
| 226791 | 1776574394 | K172205 | ExoToe Staple | JDR | 2018-01-11 |
| 344636 | 1066767260 | BK251196 | |||
| 133729 | 1488627911 | ||||
| 213136 | 1540044273 | ||||
| 336569 | 1101626328 | ||||
| 336569 | 1178877009 | ||||
| 336569 | 1309525864 | ||||
| 336569 | 1383671858 | ||||
| 305373 | 1543084349 | ||||
| 344636 | 1662818246 | ||||
| 209813 | 1814703230 | ||||
| 336569 | 1841928146 | ||||
| 291259 | 1901022042 | ||||
| 209813 | 2045177030 |
Product Codes Associated With Registrations
PMN
MicroTrend System
Exostat Medical, Inc.
AI Platform 2.0 (AIP002)
Exo Imaging
AI Platform (AIP001)
Exo, Inc.
Bladder AI (AIBV01)
Exo, Inc.
Exo Iris (El2001)
Exo Imaging Inc.
exoplan
Exocad GmbH
Exo Iris
Exo Imaging Inc.
AbutmentCAD
Exocad GmbH
ExoAtlet-II
ExoAtlet Asia Co. Ltd.
ZIDA Wearable Neuromodulation System
Exodus Innovations
Exogenesis Hernia Mesh
Exogenesis Corporation
Exoplan 2.3
Exocad GmbH
ExoToe Staple
ExoToe LLC
GLYCACOR
EXOCELL, INC.
EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI
EXONIX RESEARCH CORP.
CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002
EXOS, INC.
ATRAUMATIC TIP ANGIOGRAPHIC CATHETER
EXONIX RESEARCH CORP.
CLINICAL HANDMASTER SYSTEM OR CHMS
EXOS MEDICAL PRODUCTS
ACC.U.DIAL
EXOCELL, INC.
GLYCABEN
EXOCELL, INC.
DIALBUMIN
EXOCELL, INC.
ALBUWELL
EXOCELL, INC.
HEMOCLAV VENOUS CATHETER
EXO, INC.
IP-758 BURN WOUND DRESSING
EXOPACK