TAVIPILOT
Caranx Medical
CARA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009173317 | 3009173317 | CARAGH PRECISION | 1 | N | 2026-01-01 | Parkmore West Galway Galway IE 9999 |
| 3032760064 | 3032760064 | CARAN PRECISION ENGINEERING & MANUFACTURING CORP. | 1 | N | 2026-01-01 | 2830 Orbiter St Brea CA US 92821 |
| 3047842058 | 3047842058 | CARANX, INC. | 1 | Y | 2026-01-01 | 2093 Philadelphia Pike Pmb 3795 Claymont DE US 19703 |
| 1221553 | 1221553 | CARA, INC. | 1 | Y | 2020-04-25 | 333 Strawberry Field Rd Ste 2 WARWICK RI US 02886 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 352161 | 1957432244 | K243884 | TAVIPILOT | OWB | 2025-07-07 |
| 30574 | 1026265572 | ||||
| 30574 | 1075567450 | ||||
| 30574 | 1237250059 | ||||
| 30574 | 1293464825 | ||||
| 30574 | 1402796772 | ||||
| 30574 | 1456238375 | ||||
| 30574 | 1488434267 | ||||
| 30574 | 1563290313 | ||||
| 30574 | 1662387851 | ||||
| 30574 | 1681224826 | ||||
| 30574 | 1849179529 | ||||
| 30574 | 1875388945 | ||||
| 30574 | 1927731606 | ||||
| 30574 | 1977433901 | ||||
| 30574 | 2067358423 | ||||
| 154755 | 1018716728 | ||||
| 154755 | 1066670087 | ||||
| 154755 | 1085387831 | ||||
| 154755 | 1090623435 | ||||
| 154755 | 1091771955 | ||||
| 154755 | 1098317925 | ||||
| 154755 | 1141094509 | ||||
| 154755 | 1149850516 | ||||
| 334018 | 1200839644 | ||||
| 154755 | 1224239234 | ||||
| 154755 | 1225327171 | ||||
| 154755 | 1263564219 | ||||
| 154755 | 1299984064 | ||||
| 154755 | 1414261734 | ||||
| 334018 | 1473016108 | ||||
| 154755 | 1504967028 | ||||
| 154755 | 1533723484 | ||||
| 154755 | 1536825992 | ||||
| 154755 | 1581033269 | ||||
| 154755 | 1612480228 | ||||
| 154755 | 1639287169 | ||||
| 154755 | 1686391205 | ||||
| 154755 | 1688577771 | ||||
| 154755 | 1698182136 | ||||
| 154755 | 1706619994 | ||||
| 154755 | 1708926286 | ||||
| 154755 | 1782786623 | ||||
| 154755 | 1800655091 | ||||
| 154755 | 1816121155 | ||||
| 154755 | 1845416557 | ||||
| 154755 | 1920102477 | ||||
| 154755 | 1973676551 | ||||
| 154755 | 1977325208 | ||||
| 154755 | 2026442218 | ||||
| 154755 | 2053956100 | ||||
| 154755 | 2062363633 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OWB | 1 | 2025-07-07 |
PMN#
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
CARADYNE, LTD.
OXICHECK
CARADYNE, LTD.
CRITERION 60 OR PM 60
CARADYNE, LTD.
CRITERION 40 OR PM 40
CARADYNE, LTD.
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
CARADYNE, LTD.
CARAPACE LABOR AND DELIVERY SETS
CARAPACE, INC.
I.V. START KIT
CARAPACE, INC.
CARAPACE STILLWATER BOWL SET
CARAPACE, INC.
CARAPACE DEBRIDEMENT KITS
CARAPACE, INC.
CARAPACE PACKING GAUZE TRAYS
CARAPACE, INC.
SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
CARAPACE, INC.
CARAPACE SUTURE REMOVAL TRAYS
CARAPACE, INC.
CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
CARAPACE, INC.
CARAPACE STERILE GAUZE TRAYS
CARAPACE, INC.
CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
CARAPACE, INC.
CARAPACE CATARACT TRAYS
CARAPACE, INC.
CARAPACE STERILE CAST PADDING
CARAPACE, INC.
CARAPACE INSTRUMLENT AND INSTRUMENT SETS
CARAPACE, INC.
CARAPACE ANGIOGRAPHY TRAYS
CARAPACE, INC.
CARAPACE STERILE COTTON BALLS
CARAPACE, INC.
CARAPACE INCISION AND DRAINAGE TRAYS
CARAPACE, INC.
SYNTHETIC CAST TAPE
CARAPACE, INC.
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
CARAPACE, INC.
UNI-THANE
CARAPAC SYSTEMS, INC.
CARAFLEX ELASTIC POLYMER PLASTER BANDA
CARAPACE, INC.
SURGICAL FACE MASK
CARAPACE, INC.
PACEMAKER, OVALITH-D CARDIAC
CARATOMIC
LAP SPONGE
CARAPACE, INC.
Applications#
GUDID#
CARING MILL - HEATING PAD
2020-10-01
Cara - Heating Pad
2019-02-15
CARING MILL - CRA74
2019-08-30
CARA - 56
2019-08-30
CARA - 55
2019-08-30
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2016-07-26
Cara - Heating Pad
2018-04-23
Caring Mill - Heating Pad
2018-08-22
Caring Mill - Heating Pad
2018-08-22