| K230443 — TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223860 — Integrity Bone Staple Fixation System | Anika Therapeutics, Inc. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230460 — Laser Thermal Therapy Kit | Elesta S.P.A Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230464 — MixJect® Transfer Device | West Pharma. Services IL, Ltd. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230373 — HELIOS 785 Pico | Laseroptek Co., Ltd. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230631 — Kodiak Dual Port Coaxial Introducer Kit | Argon Medical Devices Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220722 — PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230708 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231464 — 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222705 — Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223839 — TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230465 — Hi-Bond Universal | Mediclus Co., Ltd. Mon May 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212758 — Autoplaque | Cedars-Sinai Medical Center: Aim Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231140 — aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | Microlife Intellectual Property GmbH Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230375 — BIOMONITOR IV | Biotronik, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221323 — Exactech® Alteon® Short Tapered Wedge | Exactech, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222703 — ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) | Moving Life, Ltd. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220916 — iLet® Dosing Decision Software | Beta Bionics, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222833 — Ventana C Spinal System | Spinal Elements, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Laboratories Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223486 — SafeBreak® Vascular | Lineus Medical Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222545 — Disposable Medical Mask | Guangzhou Fuzelong Hygiene Material Co., Ltd. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223846 — iLet® ACE Pump | Beta Bionics, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230537 — Klassic Knee Revision System | Total Joint Othopedics, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220402 — VirtuOst | O.N. Diagnostics Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | Qura S.R.L Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230769 — PrevisEA Device | Entac Medical, Inc. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231143 — GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230723 — C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230479 — ComASP Cefiderocol 0.008-128 | Liofilchem s.r.l. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223269 — Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223645 — I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220027 — B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230758 — uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220829 — Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222356 — Claritag Advanced | Dgi Technologies Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223725 — Restrata® MiniMatrix | Acera Surgical, Inc. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223276 — Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230432 — Single Use Bipolar Forceps | Hg Innovations, Ltd. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231113 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230200 — Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | Boston Scientific Corporation Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230448 — DeepX DermoSight Dermatoscope | Deepx Health, LLC Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231128 — JuggerKnot Soft Anchor | Riverpoint Medical, LLC Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223696 — F&P Solo Mask Range | Fisher & Paykel Healthcare, Ltd. Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230286 — Assert-IQ Insertable Cardiac Monitor | ABBOTT MEDICAL Wed May 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |