| K202163 — Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. Oct 7, 2022 |
| K222205 — Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. Oct 7, 2022 |
| K222698 — CUVIS-spine | Curexo, Inc. Oct 7, 2022 |
| K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | Guangdong Kingfa Sci. & Tech.Co., Ltd. Oct 7, 2022 |
| K213969 — VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions Oct 7, 2022 |
| K220267 — AMSafe NeuFlo Needleless Connector | Amsino International, Inc. Oct 7, 2022 |
| K213061 — SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. Oct 7, 2022 |
| K222418 — Nuvola | Gruppo Europeo Ortodonzia Srl Oct 7, 2022 |
| K220111 — RespiraSense | Pmd Solutions Oct 7, 2022 |
| K213666 — NuCath Wedge Pressure Catheter | Pfm Medical, Inc. Oct 6, 2022 |
| K221653 — InfaTherm Disposable Infant Warming Mattress | International Biomedical Oct 6, 2022 |
| K220852 — iCare IC200 | Icare Finland OY Oct 6, 2022 |
| K222080 — Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | Sg Healthcare Co, Ltd. Oct 6, 2022 |
| K222431 — b-ONER MOBIO Total Knee System | B-One Ortho, Corp. Oct 6, 2022 |
| K220365 — Gemini Sterilization Wrap | Medline Industries, LP Oct 6, 2022 |
| K212168 — A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. Oct 6, 2022 |
| K222427 — PRIMA TT Glenoid | Lima Corporate S.P.A. Oct 6, 2022 |
| K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC Oct 6, 2022 |
| K222700 — Tibial baseplate, Tibial insert | United Orthopedic Corporation Oct 6, 2022 |
| K222686 — Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. Oct 6, 2022 |
| K221889 — ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | Prosomnus Sleep Technologies Oct 6, 2022 |
| K221449 — Genius AI Detection 2.0 | Hologic, Inc. Oct 6, 2022 |
| K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. Oct 5, 2022 |
| K222737 — Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. Oct 5, 2022 |
| K221759 — Cornisol | Aurolab Oct 5, 2022 |
| K222515 — FaSet Fixation System | Dio Medical Corporation Oct 5, 2022 |
| K221128 — Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. Oct 5, 2022 |
| K220546 — Colibrí System | Copan Wasp Srl Oct 5, 2022 |
| K220138 — Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP | Led Spa Oct 5, 2022 |
| K220140 — ClearCorrect System | Clearcorrect, LLC Oct 5, 2022 |
| K221892 — VISIONAIR | Pacificmd Biotech, LLC Oct 5, 2022 |
| K221994 — Hailie Sensor NF0107 & NF0108 | Adherium (Nz), Ltd. Oct 4, 2022 |
| K221080 — Sterile Safety Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. Oct 4, 2022 |
| K221517 — POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens | INTEROJO, Inc. Oct 4, 2022 |
| K221928 — ROSA® Knee System | Orthosoft D/B/A Zimmer Cas Oct 4, 2022 |
| K221066 — Sterile Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. Oct 4, 2022 |
| K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. Oct 4, 2022 |
| K221079 — Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. Oct 4, 2022 |
| K221068 — Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. Oct 4, 2022 |
| K222743 — Route 92 Medical Full Length 070 Access System | Route 92 Medical, Inc. Oct 4, 2022 |
| K221646 — CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. Oct 4, 2022 |
| K220683 — INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | Penumbra, Inc. Oct 4, 2022 |
| K213464 — HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO Oct 4, 2022 |
| K222380 — TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. Oct 4, 2022 |
| K221778 — Disposable Safety Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. Oct 3, 2022 |
| K213842 — ONVOY Acetabular System | Globus Medical, Inc. Oct 3, 2022 |
| K220220 — Electronic Sphygmomanometer (Model: LT-P30) | Zhuhai Linte Medical Instrument Co., Ltd. Oct 3, 2022 |
| K222267 — Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. Oct 3, 2022 |
| K221047 — SILO TFX MIS Sacroiliac Joint Fixation System | Aurora Spine, Inc. Oct 3, 2022 |
| K202953 — Aurolase Therapy, Laser Delivery Device (LDD) | Nanospectra Biosciences, Inc. Oct 3, 2022 |