| ControlSeal Electrode (ELSB) (K223605) | Coapt | 2022-12-30 |
| Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (K221358) | AtriCure, Inc. | 2022-12-30 |
| PeekMed web (v1) (K222767) | Peek Health, S.A. | 2022-12-30 |
| Biobeat Platform-2 and BB-613WP Patch (K222010) | Biobeat Technologies , Ltd. | 2022-12-30 |
| EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (K210313) | Shanghai Microport EP Medtech Co., Ltd. | 2022-12-30 |
| Cyware 4H and Cysart 4H (K221796) | Abys Medical | 2022-12-30 |
| aprevo® Digital Workflow (K222195) | Carlsmed, Inc. | 2022-12-30 |
| Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) | Boston Scientific Corporation | 2022-12-30 |
| Persyst 15 EEG Review and Analysis Software (K222002) | Persyst Development Corporation | 2022-12-30 |
| X-ray Flat Panel Detectors (EverestView 4343X) (K223687) | Careray Digital Medical Technology Co., Ltd. | 2022-12-30 |
| Aesculap AICON Container (K214041) | Aesculap, Inc. | 2022-12-30 |
| DNA Appliance (K222872) | Vivos Therapeutics, Inc. | 2022-12-30 |
| CMFlexTM (K213260) | Dimension Inx Corp. | 2022-12-30 |
| Fingertip Pulse Oximeter (K213430) | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022-12-30 |
| BioClean Implant Restorative System (K222984) | Bioclean Dental, LLC | 2022-12-29 |
| Reflow System Mini and ReFlow Mini Flusher (K223603) | Anuncia Medical, Inc. | 2022-12-29 |
| AG100s (K221477) | Hospitech Respiration , Ltd. | 2022-12-29 |
| Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K223592) | Boston Scientific Corporation | 2022-12-29 |
| OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) (K221690) | Olympus Medical Systems Corp. | 2022-12-29 |
| Multi-Parameter Patient Monitor (K211619) | Shenzhen Comen Medical Instruments Co.,Ltd | 2022-12-29 |
| Atalante (K221859) | Wandercraft SAS | 2022-12-29 |
| EndoPATx (K211557) | Itamar Medical , Ltd. | 2022-12-29 |
| SafeR Syringe and SafeR Sting (K221981) | Roncadelle Operations Srl | 2022-12-29 |
| Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (K221333) | Acumed, LLC | 2022-12-29 |
| Total Bilirubin2 (K223324) | Abbott Ireland Diagnostics Division | 2022-12-29 |
| Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App (K220935) | Iren-Medical, Ltd. | 2022-12-29 |
| Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode (K222528) | Well-Life Healthcare Limited | 2022-12-29 |
| CLEAR+BRILLIANT TOUCH® Laser System (K223647) | Solta Medical, Inc. | 2022-12-29 |
| BD AutoShield Duo™ Pen Needle (K223286) | Becton, Dickinson and Company | 2022-12-28 |
| StageOne™ Select Hip Cement Spacer Molds (K222760) | Biomet, Inc. | 2022-12-28 |
| Medussa-PL Cage (K223654) | Medyssey USA, Inc. | 2022-12-28 |
| RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (K221660) | Olympus Medical Systems Corp. | 2022-12-28 |
| nView s1 with nav option (K221344) | Nview Medical | 2022-12-28 |
| R:GEN (K220974) | Lutronic Vision, Inc. | 2022-12-27 |
| EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License (K223094) | ABBOTT MEDICAL | 2022-12-27 |
| Access Total ßhCG (5th IS) (K221990) | Beckman Coulter, Inc. | 2022-12-27 |
| Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978) | Xiros, Ltd. | 2022-12-27 |
| IOB Warming Blankets (K221669) | Iob Medical, Inc. | 2022-12-27 |
| CRYOcheck Chromogenic Factor IX (K214002) | Precision Biologic, Inc. | 2022-12-23 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K223565) | L&K BIOMED Co., Ltd. | 2022-12-23 |
| BioXmark (DEN220017) | Nanovi A/S | 2022-12-23 |
| STA- NeoPTimal (K211485) | Diagnostica Stago S.A.S | 2022-12-23 |
| ACTOnco, ACTOnco IVD (K210017) | Act Genomics | 2022-12-23 |
| XENOVIEW 3.0T Chest Coil (K212239) | Polarean, Inc. | 2022-12-23 |
| Access Vitamin B12 (K223289) | Beckman Coulter, Inc. | 2022-12-23 |
| Visant Medical Canalicular Plug (K222164) | Visant Medical, Inc. | 2022-12-23 |
| Episealer Patellofemoral System (K221048) | Episurf Medical, Inc. | 2022-12-23 |
| Smartpump 3.0 Double Electric Breast Pump (K222726) | Lansinoh Laboratories | 2022-12-23 |
| Leg Massager RF-ALM070 (K222924) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2022-12-23 |
| MR 5300 and MR 7700 R11 MR Systems (K223442) | Philips Medical Systems Nederlands B.V. | 2022-12-23 |
| OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (K221193) | OSSIO , Ltd. | 2022-12-23 |
| AVIEW (K214036) | Coreline Soft Co., Ltd. | 2022-12-23 |
| CIMILRE Free-T2 Plus (K221708) | Cimilre Co., Ltd. | 2022-12-23 |
| ONLINE DAT Benzodiazepines II (K221765) | Roche Diagnostics | 2022-12-23 |
| ShiNeo Silicone Implant (K222748) | Shineo Technology Co., Ltd. | 2022-12-23 |
| Xenoview VDP (K223071) | Polarean, Inc. | 2022-12-23 |
| Invisalign System, Pre-Formed Attachment System (K222894) | Align Technology, Inc. | 2022-12-22 |
| iFuse Bedrock Granite® Implant System (K222774) | SI-BONE, Inc. | 2022-12-22 |
| Air Compression Leg Massager (Model: LY-670D) (K222949) | Zhejiang Luyao Electronics Technology Co., Ltd. | 2022-12-22 |
| Kodiak C Spinal Implant System (K222806) | Met One Technologies, LLC | 2022-12-22 |
| Lp(a) Ultra (K211058) | SENTINEL CH. SpA | 2022-12-22 |
| Tesera-K SC System (K223105) | Kyocera Medical Technologies, Inc. | 2022-12-22 |
| PerioStom Dental Dressing (K221428) | Forward Science, LLC | 2022-12-22 |
| Coltolux Comfort LED Curing Light (K223142) | Dent4you AG | 2022-12-22 |
| VERTICALE® Navigation Instruments (K223649) | Silony Medical GmbH | 2022-12-22 |
| Philips CT 3500 (K223311) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-12-22 |
| Biograph Vision Quadra PET/CT System (K223547) | Siemens Medical Solutions USA, Inc. | 2022-12-22 |
| Sunrise (K222262) | Sunrise SA | 2022-12-22 |
| SteriKing LT-Blueline Pouches with Tyvek (K221377) | Wipak OY | 2022-12-22 |
| Arthrex FiberTak Suture Anchor (K221396) | Arthrex, Inc. | 2022-12-22 |
| Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device (K223508) | Medtronic, Inc. | 2022-12-22 |
| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
| ASTRA Spine System (K223273) | Spinecraft, LLC | 2022-12-22 |
| CORE-INJECTOR (K221054) | Incore Co., Ltd. | 2022-12-21 |
| AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (K222867) | Andon Health Co, Ltd. | 2022-12-21 |
| 8MP Color LCD Monitor CL-R813 (K222864) | Jvckenwood Corporation | 2022-12-21 |
| CURA-Temp (K202965) | Mgnewton , Ltd. | 2022-12-21 |
| BiWaze Clear System (K213564) | Abmrc, LLC | 2022-12-21 |
| Comfort Gown, Safewear Gown (K213893) | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2022-12-21 |
| inspired™ VHB20 Heated Humidifier (K222351) | Vincent Healthcare Products Limited | 2022-12-21 |
| BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826) | Becton, Dickinson and Company | 2022-12-21 |
| TriMed Wrist Fixation System 3 (K222637) | TriMed, Inc. | 2022-12-21 |
| NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (K222538) | Sino Medical Sciences Technology, Inc. | 2022-12-21 |
| LimFlow Vector (K221902) | LimFlow, Inc. | 2022-12-21 |
| reVive Light Therapy® Wrinkle and Acne LED Device (K223482) | Led Technologies, Inc. | 2022-12-21 |
| Extra Silver Gelling Fiber Dressing (K221720) | Winner Medical Co., Ltd. | 2022-12-21 |
| Mural Clinical Viewer (K222586) | Ge Medical Systems Information Technologies, Inc. | 2022-12-21 |
| AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (K223050) | MicroVention, Inc. | 2022-12-21 |
| Pristine Arthroscopic Visualization System (K223244) | Pristine Surgical | 2022-12-21 |
| GlucoSure ADVANCE Link Blood Glucose Monitoring System (K222234) | Apex BioTechnology Corp. | 2022-12-21 |
| VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP (K221911) | Vinno Technology (Suzhou) Co.,Ltd | 2022-12-21 |
| PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System (K213235) | Pentax of America, Inc. | 2022-12-21 |
| DRI TM Tricyclics Serum Tox Assay (K213875) | Microgenics Corporation | 2022-12-21 |
| ELECTROCYN soma (K220286) | V3Bio Sdn. Bhd | 2022-12-21 |
| Advanced Intramedullary Nail System (K221221) | Double Medical Technology, Inc. | 2022-12-21 |
| Eargo 5 , Eargo 6 (K221698) | Eargo, Inc. | 2022-12-21 |
| BresoDX1 (K220012) | Bresotec, Inc. | 2022-12-21 |
| DP4 Microneedling device (K221070) | Equipmed USA, LLC | 2022-12-20 |
| Smart SPACE Shoulder Planner and 3D Positioners (K222405) | Lima Corporate S.P.A. | 2022-12-20 |
| Invictus® Bone Cement, Invictus Spinal Fixation System (K221926) | Alphatec Spine, Inc. | 2022-12-20 |