| RCT800 (K230753) | Ray Co., Ltd. | 2023-04-11 |
| ENROUTE® Transcarotid Neuroprotection System (K230402) | Silk Road Medical | 2023-04-11 |
| Ultrasound System 2300 (K223830) | Bk Medical Aps | 2023-04-11 |
| Neuspera Nuity System (K221303) | Neuspera Medical, Inc. | 2023-04-11 |
| APRO 70 Catheter and Alembic Aspiration Tubing (K230695) | Alembic, LLC | 2023-04-10 |
| Arthrex Univers Revers Monoblock Stem Size 4/33 (K230366) | Arthrex, Inc. | 2023-04-10 |
| Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (K222887) | Famidoc Technology Company Limited | 2023-04-10 |
| MISHA Knee System (DEN220033) | Moximed, Inc. | 2023-04-10 |
| DMX (K223550) | Del Medical, Inc. | 2023-04-10 |
| IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG (K230122) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2023-04-10 |
| ARIA Radiation Therapy Management (v18.0) (K230699) | Varian Medical Systems, Inc. | 2023-04-10 |
| Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister (K223176) | Argon Medical Devices, Inc. | 2023-04-10 |
| TENS and EMS Stimulation (OTC) (K230164) | Changsha Yuwen Medical Equipment Co., Ltd. | 2023-04-10 |
| IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 (K230360) | Shenzhen Jizhimei Technology Co., Ltd. | 2023-04-10 |
| SKOUT® system (K230658) | Iterative Scopes, Inc. | 2023-04-07 |
| Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (K223640) | Axogen Corporation | 2023-04-07 |
| Mazor X System (Mazor X Stealth Edition) (K230064) | Mazor Robotics , Ltd. | 2023-04-07 |
| Limbus Contour (K230575) | Limbus Ai, Inc. | 2023-04-07 |
| Peri-Guard and Supple Peri-Guard (K223052) | Synovis Life Technologies, Inc. | 2023-04-07 |
| The N-SWEAT Patch (DEN210055) | Candesant Biomedical, Inc. | 2023-04-07 |
| Elecsys FT4 IV (K220456) | Roche Diagnostics | 2023-04-07 |
| BD SmartSite™ Needle-Free Connector (K223088) | Care Fusion | 2023-04-07 |
| Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318) | Corcym S.r.l. | 2023-04-07 |
| Axiostat Gauze (K222909) | Advamedica, Inc. | 2023-04-07 |
| Enivo™ (K223373) | Aroa Biosurgery , Ltd. | 2023-04-07 |
| PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772) | Stryker GmbH | 2023-04-07 |
| Dental CT Scanner AXR (K223816) | Alliage S/A Industrias Medico Odontológica | 2023-04-07 |
| AI-Rad Companion (Cardiovascular) (K222360) | Siemens Medical Solutions U.S.A. | 2023-04-06 |
| CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) (K223531) | GE Healthcare Finland Oy | 2023-04-06 |
| S.I.N. Dental Implant System (K230069) | S.I.N. – Sistema DE Implante Nacional S.A. | 2023-04-06 |
| ACRIFIX (K230341) | Deltamed GmbH | 2023-04-06 |
| RayFlow (K222023) | Hexacath | 2023-04-06 |
| Contour ProtégéAI (K223774) | Mim Software, Inc. | 2023-04-06 |
| Affinity Fusion™ Oxygenator System (K230640) | Medtronic, Inc. | 2023-04-06 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems (K223458) | Philips Medical Systems Nederland B.V. | 2023-04-06 |
| Disposable Insulin Pen Needle (K222739) | Hantech Medical Device Co., Ltd. | 2023-04-06 |
| EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert (K230169) | Encore Medical, L.P Dba Enovis | 2023-04-06 |
| IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 (K230097) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2023-04-06 |
| QUANTUM Patient Specific Instrumentation (PSI) System (K230313) | In2bones Sas | 2023-04-06 |
| F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197) | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 |
| Nightwear Aligners (K221537) | Smylio, Inc. | 2023-04-05 |
| Da Vinci SP Surgical System (SP1098) (K230033) | Intuitive Surgical, Inc. | 2023-04-05 |
| CO2 Mainstream Sensor (K221118) | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) (K230336) | Light Tree Ventures Europe B.V. | 2023-04-05 |
| MicroScan Prompt Inoculation System-D (K221493) | Beckman Coulter, Inc. | 2023-04-05 |
| Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System (K223630) | Medtronic, Inc. | 2023-04-05 |
| N2 (K211556) | Megagen Implant Co., Ltd. | 2023-04-05 |
| T-FIX™ 3DSI Joint Fusion System (K230689) | Cutting Edge Spine, LLC | 2023-04-05 |
| Antimicrobial Silicone PHMB Foam Wound Dressing (K223310) | Advanced Medical Solutions Limited | 2023-04-05 |
| BioSci™ Disposable Virus Sampling Tubes (K230035) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-04-05 |
| Optimos™ Cystotome (K223256) | Taewoong Medical Co., Ltd. | 2023-04-05 |
| D·Kaptain PTA High Pressure Balloon Dilatation Catheter (K214009) | Dk Medical Technology Co., Ltd. | 2023-04-05 |
| Intermittent nelaton catheter for single use (K222677) | Hangzhou Jimushi Meditech Co., Ltd. | 2023-04-05 |
| Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 (K230107) | Kam Yuen Plastic Products , Ltd. | 2023-04-05 |
| FAQ 101 (K222012) | Foreo, Inc. | 2023-04-05 |
| Reprocessed NRG Transseptal Needle (K213584) | Innovative Health, LLC | 2023-04-04 |
| BRM Digitalis Spacer (K220142) | Brm Extremities Srl | 2023-04-04 |
| NeuroStar Advanced Therapy System (Version 3.7) (K230029) | Neuronetics | 2023-04-04 |
| Ballancer Platinum (1222) (K230385) | Mego Afek | 2023-04-04 |
| Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (K220454) | Avation Medical, Inc. | 2023-04-03 |
| Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly (K230028) | Cardinal Health200, LLC | 2023-04-03 |
| Sclerotherapy & Endoscopic Needles (K222006) | G-Flex Europe Sprl | 2023-04-03 |
| Annalise Enterprise CTB Triage Trauma (K223240) | Annalise-Ai Pty , Ltd. | 2023-04-03 |
| G7, Dental Operative Unit and Accessories (K213749) | Shinhung Company, Ltd. | 2023-04-03 |
| M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle (K222865) | Canyon Medical, Inc. | 2023-04-03 |
| iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (K221802) | Mawi Dna Technologies | 2023-04-03 |
| SpO2 Extension Cable (K222370) | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2023-04-02 |
| FiberTak Suture Anchor (K230568) | Arthrex, Inc. | 2023-04-01 |
| Maxtec MaxO2 ME+p (K221734) | Maxtec, LLC | 2023-04-01 |
| Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K230003) | Topzir Biotech Co., Ltd. | 2023-03-31 |
| Spectrum IQ Infusion System with Dose IQ Safety Software (K230041) | Baxter Healthcare Corporation | 2023-03-31 |
| SonoAir Series Digital Color Doppler Ultrasound System (K223570) | CHISON Medical Technologies Co., Ltd. | 2023-03-31 |
| BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx (K230238) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2023-03-31 |
| RadAlly (K213660) | Imaging Wave, LLC | 2023-03-31 |
| Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K230022) | Baxter Healthcare Corporation | 2023-03-31 |
| Iris AirShuttle™ (K230312) | Qfix | 2023-03-31 |
| IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 (K230021) | Shenzhen Yangyi Technology ., Ltd. | 2023-03-31 |
| 1788 4K Camera System with Advanced Imaging Modality (K230605) | Stryker | 2023-03-31 |
| Formus Hip (K213272) | Formus Labs, Ltd. | 2023-03-31 |
| Butterfly iQ/iQ+ Ultrasound System (K220068) | Butterfly Network, Inc. | 2023-03-31 |
| CereFlow™ V1.2 (K211059) | Translational Mri, LLC | 2023-03-31 |
| ROVO Mechanical Thrombectomy Device (K220780) | 2mg, Inc. | 2023-03-31 |
| Medical Diode Laser (M2) (K230274) | Wuhan Pioon Technology Co., Ltd. | 2023-03-31 |
| Diode Laser Hair Removal System (RD-SLD600) (K223778) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-03-31 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017) | Canon Medical Systems Corporation | 2023-03-31 |
| Aspirex™ Thrombectomy System (K230356) | C.R. Bard, Inc. | 2023-03-31 |
| Masimo SafetyNet (DEN200011) | Masimo Corporation | 2023-03-31 |
| Axiom PSR System (K223326) | Restor3D | 2023-03-30 |
| SNOO Smart Sleeper (DEN210039) | Happiest Baby, Inc. | 2023-03-30 |
| Maestro Microcatheter (K230636) | Merit Medical System, Inc. | 2023-03-30 |
| Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K220088) | Professional Latex Sdn Bhd | 2023-03-30 |
| ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (K221324) | Camber Spine Technologies | 2023-03-30 |
| Medartis APTUS® Ulna Plates (K223853) | Medartis AG | 2023-03-30 |
| MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System (K223342) | Crossroads Extremity Systems, LLC | 2023-03-30 |
| BIASURGE Advanced Surgical Solution (K223377) | Rochal Technologies, LLC | 2023-03-30 |
| HOPKINS Telescopes (K223923) | KARL STORZ Endoscopy-America, Inc. | 2023-03-30 |
| Comfort Marker 2.0 (K222112) | Medical Precision BV | 2023-03-30 |
| ARDO Bellis (K230590) | Ardo Medical AG | 2023-03-30 |
| ONLINE TDM Phenytoin - Free Phenytoin application (K230161) | Roche Diagnostics | 2023-03-30 |
| Cemented Tibia Baseplate no Taper with JRNY Lock (K230555) | Smith & Nephew, Inc. | 2023-03-30 |