This page includes the latest FDA filings for Unite Medical L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3015727296 |
| FEI Number | 3015727296 |
| Name | UNITE MEDICAL, LLC |
| Owner & Operator | Unite Medical, LLC |
| Contact Address | 3350 Riverwood Pkwy Suite 1900 Atlanta GA 30339 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2167 Weldonberry Drive NE Brookhaven, GA 30319 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Unite Medical, LLC | Unite Medical® PWB6061-XS-S | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-S-S | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-M-S | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-L-S | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-XL-S | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-XL-T | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-L-T | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-M-T | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-S-T | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® PWB6061-XS-T | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® Cyro3670 | 2024-06-28 |
| Unite Medical, LLC | Unite Medical® HS3170-XL | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® HS3170-L | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® HS3170-M | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® HS3170-S | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® LSO3148 | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® LSO3750 | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® AFO0671R-L | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® AFO0671R-M | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® AFO0671R-S | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® AFO0671L-L | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® AFO0671L-M | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® AFO0671L-S | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552R-XL | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552R-L | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552R-M | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552L-XL | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552L-L | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552L-M | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552R-S | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4552L-S | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® SS2397 | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4351R | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO4351L | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO3233-1 | 2024-01-05 |
| Unite Medical, LLC | Unite Medical® KO3233 | 2024-01-05 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
UNITE MEDICAL, LLC | Unite Medical | 2019-12-20 |
| NCAGE Code | 8MK70 | UNITE MEDICAL, LLC |
| CAGE Code | 8MK70 | UNITE MEDICAL, LLC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020082445692 | Yantian,China (Mainland) -> Los Angeles, California | DEXIUE UNIVERSAL ROM KNEE BRACES HS CODE:9021.10 4PLTS=100CTNS . . . . | 100 CTN |
| 2020080723061 | Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey | ROM KNEE BRACES BABY CRADLE LSO POST-OPERATIVE KNEE BRACES ROM ELBOW BRACES CRYO PNEUMATIC ELBOW CRYO PNEUMATIC ANKLE CRYO PNEUMATIC ROM KNEE CRYO PNEUMATIC SHOULDER WRIST HAND ORTHOSIS WRIST HAND FINGER ORTHOSIS CERVICAL COLLARS HIP ORTHOSIS ANKLE FOOT | 253 CTN |
| 2020041727564 | Yantian,China (Mainland) -> Los Angeles, California | LUMBAR SACRAL ORTHOSIS LUMBAR ORTHOSIS ZIPLOC K BAGS | 262 CTN |
| 2020021336759 | Wuhu,China (Mainland) -> Los Angeles, California | COMMODITY: UNIVERSAL ROM KNEE BRACES HS CODE:950699 2PKGS=2PLTS . . . | 2 PKG |