| K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232790 — KONG®-TL VBR System and KONG® C VBR System | Icotec AG Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240038 — Clear Moves Aligners | Space Maintainers Laboratories (Sml) Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232227 — ABLATE-IQ | Neuwave Medical, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231834 — VSP PEEK Cranial Implant | 3D Systems, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232114 — TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240639 — PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240361 — Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233910 — Vertex Hip Fracture Nailing System | Orthoxel Dac Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240172 — Preview Shoulder | Genesis Software Innovations Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240071 — Peleton Universal Single Use Power System and Attachments | Peleton Surgical Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233548 — Uresta® | Resilia, Inc. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) | Dongguan Boyuan Intelligent Technology Co.,Ltd Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230889 — Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240350 — AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240135 — Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233618 — Oxevision Sleep Device | Oxehealth Limited Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232899 — AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. Wed Apr 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232835 — Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240888 — Calibra Abutment Resin Cement | Dentsply Sirona Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Syntex Healthcare Products Co., Ltd. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233975 — Zoom 6F Insert Catheters | Imperative Care, Inc. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232112 — R&G Surgical Mask | R&G Seguridad E Higiene Industrial S.A.C. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233750 — ECG-less Cardiac | Ge Medical Systems, LLC Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230036 — Sepsis ImmunoScore | Prenosis, Inc. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240601 — SnapshotNIR model KD205 | Kent Imaging, Inc. Tue Apr 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240635 — ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm | Ximedica Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240043 — EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Microport Orthopedics, Inc. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232726 — External Hex Implant System | Southern Implants (Pty), Ltd. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233676 — Us2.v2 | Eko.Ai Pte Ltd. D/B/A Us2.Ai Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233990 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Shandong Xingyu Gloves Co., Ltd. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233133 — Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240442 — MagnetOs Putty | Kuros Biosciences B.V Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240288 — SF Push- in Anchor | Surgical Fusion Technologies GmbH Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240397 — AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231209 — Rejoyn | Otsuka America Pharmaceutical, Inc. Sat Mar 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233211 — AVIEW CAC | Coreline Soft Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233068 — Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233622 — AlignRT Plus | Vision Rt, Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232018 — Citrated: K, KH, RTH, FFH | Haemonetics Corporation Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230665 — Dose IQ Safety Software | Baxter Healthcare Corporation Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |