| 300580 | 1602890858 | K260320 | Lunit INSIGHT MMG (v1.1.10) | QDQ | 2026-04-23 |
| 23192 | 1527005876 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | OAS | 2026-03-31 |
| 300580 | 1857522430 | K253796 | Lunit INSIGHT DBT (V1.2) | QDQ | 2026-03-26 |
| 293712 | 1308617180 | K253348 | TargetCool-e | GEH | 2025-10-15 |
| 293712 | 1049352269 | K253114 | TargetCool™ (RM-DT02W) | GEH | 2025-10-16 |
| 307419 | 1763227380 | K250518 | SMART M-CELL Bone Marrow Concentration System | QBV | 2026-04-02 |
| 307419 | 2024633818 | K250516 | SMART M-CELL PRP Concentration System | QBV | 2026-04-02 |
| 334293 | 1164091230 | K250170 | PHAROS | KPS | 2025-08-15 |
| 23192 | 1201250316 | K243088 | Green X 12 SE (PHT-40CHS) | OAS | 2025-02-21 |
| 23192 | 1256187677 | K243081 | Green X 21 (PHT-90CHO) | OAS | 2025-02-14 |
| 300580 | 1005884959 | K242652 | Lunit INSIGHT DBT v1.1 | QDQ | 2024-10-04 |
| 310484 | 2027679193 | K242583 | AT-Patch (ATP-C130/ATP-C70) | DSH | 2025-05-02 |
| 23192 | 1091982506 | K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | MUH | 2024-10-25 |
| 323432 | 1098103581 | K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | OWB | 2023-11-16 |
| 18742 | 1389506054 | K232143 | Applanation Tonometer HT-5000 | HKY | 2023-10-23 |
| 23192 | 1452917792 | K231796 | Grreen X 12 (Model: PHT-75CHS) | OAS | 2023-07-19 |
| 300580 | 1011360573 | K231470 | Lunit INSIGHT DBT | QDQ | 2023-11-06 |
| 78844 | 1945692998 | K231437 | LF900 | IRP | 2023-07-19 |
| 323432 | 1877370948 | K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | KPR | 2023-11-02 |
| 23192 | 1106382442 | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | EHD | 2022-10-26 |
| 298236 | 2041721642 | K222738 | Point implant system | DZE | 2023-04-13 |
| 286089 | 1542827144 | K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG | MQB | 2022-05-13 |
| 20104 | 1016524348 | K213749 | G7, Dental Operative Unit and Accessories | EIA | 2023-04-03 |
| 286089 | 1313660745 | K213520 | AXIR-CX | LLZ | 2022-08-19 |
| 231317 | 2068452660 | K213405 | MINE ALNU (Model: Mine 2.1) | IZL | 2022-07-10 |
| 300580 | 1089538935 | K211733 | Lunit INSIGHT CXR Triage | QFM | 2021-11-10 |
| 300580 | 1563445143 | K211678 | Lunit INSIGHT MMG | QDQ | 2021-11-17 |
| 23192 | 1077659445 | K210329 | Green X 18(Model : PHT-75CHS) | OAS | 2021-02-18 |
| 23192 | 1889480654 | K203797 | vatech A9 (Model : PHT-30CSS) | OAS | 2021-01-25 |
| 23192 | 1296699662 | K203667 | EzRay M (Model: VMX-P300) | IZL | 2021-02-02 |
| 78844 | 1056911615 | K203498 | LX9max | IRP | 2021-07-02 |
| 78844 | 1395041721 | K203417 | DVT-4000S | JOW | 2021-03-28 |
| 78844 | 1270837412 | K203353 | DVT-PRO | JOW | 2021-04-22 |
| 78844 | 1158324056 | K203016 | DVT-2600 | JOW | 2020-12-05 |
| 78844 | 1606784836 | K202395 | SP-1000, SP-2000 | IRP | 2021-09-01 |
| 18742 | 1453643822 | K202097 | Fundus Camera | HKI | 2021-02-02 |
| 23192 | 2029950562 | K201627 | Dental Computed Tomography X-Ray System, Green X | OAS | 2020-10-27 |
| 237346 | 1260954182 | K200787 | BSD3543W | MQB | 2020-04-23 |
| 23192 | 1466716974 | K200182 | EzRay Air Portable (Model: VEX-P300) | EHD | 2020-02-11 |
| 18742 | 1647793343 | K191615 | Huvitz Imaging System | NFJ | 2019-07-18 |
| 286089 | 1763196869 | K180989 | PEDRA-17F Digital Flat Panel X-ray Detector | MQB | 2018-06-13 |
| 231317 | 1040042320 | K180671 | MINE | EHD | 2019-06-05 |
| 226311 | 1206186413 | K171890 | BEXCORE Breast Biopsy System, Biopsy Needle | KNW | 2018-08-20 |
| 237346 | 1927337273 | K171485 | BSD4343R Digital Flat Panel X-ray Detector | MQB | 2017-06-21 |
| 23192 | 1613373641 | K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | MUH | 2017-04-04 |
| 23192 | 1169025243 | K170066 | Green16/Green18 (Model: PHT-65LHS) | OAS | 2017-06-16 |
| 23192 | 1608534409 | K163705 | EzRay Air W | EHD | 2017-01-24 |
| 323432 | 1569042729 | K163140 | SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System | OWB | 2017-05-26 |
| 23192 | 1100911131 | K162660 | Green Smart (Model: PHT-35LHS) | OAS | 2016-10-20 |
| 237346 | 1075686045 | K162487 | BSD3543 Digital Flat Panel X-ray Detector | MQB | 2016-10-14 |
| 18742 | 1257307628 | K161829 | Huvitz Imaging System | NFJ | 2017-04-06 |
| 23192 | 2035168929 | K161063 | EzRay Air (Model VEX-P300) | EHD | 2016-09-01 |
| 23192 | 1352291723 | K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | OAS | 2016-10-28 |
| 237346 | 1686616581 | K160204 | BSD4343 Digital Flat Panel X-ray Detector | MQB | 2016-06-09 |
| 323432 | 1512656362 | K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | OXO | 2016-05-20 |
| 23192 | 1588628530 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | OAS | 2015-10-23 |
| 20104 | 1852824546 | K151996 | TAURUS C1 | EIA | 2016-01-22 |
| 78844 | 2039145781 | K150980 | Venous Assist System | JOW | 2016-05-12 |
| 78844 | 1520823890 | K150033 | Air Compressible Limb Therapy System | IRP | 2015-04-20 |
| 323432 | 1411820069 | K133695 | TITAN 11 | KPR | 2014-08-07 |
| 323432 | 1326529569 | K132289 | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM | JAA | 2014-06-16 |
| 23192 | 1352767633 | K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | 2013-07-15 |
| 23192 | 1856233891 | K130432 | PHT-6500, PHT-60CFO | OAS | 2013-05-31 |
| 23192 | 1426285147 | K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM | EHD | 2012-12-13 |
| 23192 | 1206905817 | K122606 | PHT-6500; PHT-60CFO; PAX-I3D | OAS | 2012-11-20 |
| 23192 | 1914284542 | K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | 2012-09-04 |
| 23192 | 1457101108 | K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | 2012-03-27 |
| 78844 | 1604245828 | K112677 | THE VENOUS ASSIST SYSTEM | JOW | 2012-01-13 |
| 78844 | 1582655186 | K112441 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM | IRP | 2012-01-17 |
| 78844 | 1123499083 | K102320 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) | IRP | 2011-03-04 |
| 23925 | 1487715074 | K102223 | CHALLENGE-EVER | EIA | 2011-02-25 |
| 18742 | 1374594482 | K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | HJO | 2009-12-03 |
| 18742 | 1190346594 | K073190 | SLIT LAMP | HJO | 2008-01-11 |
| 293712 | 1488465432 | DEN230011 | OcuCool | QZQ | 2024-09-30 |
| 78844 | 1082366299 | | | | |
| 206112 | 1214870654 | | | | |
| 78844 | 1231979546 | | | | |
| 20104 | 1283008646 | | | | |
| 78844 | 1744348246 | | | | |
| 20104 | 1091825482 | | | | |
| 298236 | 1098912439 | | | | |
| 18742 | 1108212952 | | | | |
| 18742 | 1130943610 | | | | |
| 18742 | 1131600758 | | | | |
| 18742 | 1158862248 | | | | |
| 18742 | 1181756927 | | | | |
| 18742 | 1186444127 | | | | |
| 18742 | 1222522470 | | | | |
| 18742 | 1236651756 | | | | |
| 18742 | 1334094218 | | | | |
| 321322 | 1334854033 | | | | |
| 18742 | 1336416500 | | | | |
| 20104 | 1371719799 | | | | |
| 20104 | 1377416346 | | | | |
| 18742 | 1574313299 | | | | |
| 23925 | 1621574581 | | | | |
| 18742 | 1647778658 | | | | |
| 18742 | 1653091808 | | | | |
| 20104 | 1679929538 | | | | |
| 345030 | 1689538106 | | | | |
| 344325 | 1762941192 | | | | |
| 20104 | 1781202584 | | | | |
| 307419 | 1937940106 | | | | |