| CUPTIMIZE™ Advanced (K231503) | DePuy Orthopaedics, Inc. | 2023-08-22 |
| 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (K232190) | Medtronic Vascular | 2023-08-22 |
| TITAN 3-D Wedge System (K231496) | Paragon 28, Inc. | 2023-08-22 |
| Cove Strip (K230486) | SeaSpine Orthopedics Corporation | 2023-08-21 |
| Grappler Suture Anchor System (K231867) | Paragon 28, Inc. | 2023-08-21 |
| Stable-C Interbody System (K231763) | Nexus Spine, LLC | 2023-08-21 |
| Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731) | Mcgovern Medical School | 2023-08-21 |
| Plato 17 Microcatheter (K223560) | Scientia Vascular, Inc. | 2023-08-21 |
| SM-IV (K232185) | Sedecal., Sa. | 2023-08-21 |
| ACR Screw System (K222245) | Biomaterials Korea, Inc. | 2023-08-21 |
| Aveta System 2.0 (K223813) | Meditrina, Inc. | 2023-08-21 |
| Pediatric Nailing Platform Tibia (K231266) | OrthoPediatrics Corp. | 2023-08-21 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K232157) | Stryker Corporation | 2023-08-18 |
| Unicare (K-UNICARE-USA) (K231053) | Tenscare, Ltd. | 2023-08-18 |
| Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (K231262) | Stryker GmbH | 2023-08-18 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) (DEN230019) | Boston Scientific Corporation | 2023-08-18 |
| Holmium Medical Laser (K231718) | Allengers Global Healthcare Private Limited | 2023-08-18 |
| UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio (K232498) | Ultradent Product, Inc. | 2023-08-18 |
| ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing (K223526) | Smith & Nephew Medical Limited | 2023-08-18 |
| Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs (K222993) | Sentienx Sdn Bhd | 2023-08-18 |
| Smart Wedge algorithm (K230579) | Edwards Lifesciences, LLC | 2023-08-18 |
| Eco Abutment, Multiunit Abutment (K220253) | Dio Corporation | 2023-08-18 |
| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
| 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) (K231026) | Shenzhen Beacon Display Technology Co., Ltd. | 2023-08-18 |
| Pangea Utility Plating System, Pangea Platform (K231257) | Stryker GmbH | 2023-08-18 |
| ZSFab Cervical Interbody System (K232150) | Zsfab, Inc. | 2023-08-18 |
| 1.5T HD T/R Knee Array (10-F34127) (K231085) | Shenzhen RF Tech Co., Ltd. | 2023-08-18 |
| Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (K231204) | Cochlear | 2023-08-18 |
| Daye Tampon (K223883) | Annes Daye, Ltd. | 2023-08-18 |
| Avéli (K232153) | Revelle Aesthetics, Inc. | 2023-08-18 |
| SPARK Scan (K231457) | Spark Neuro, Inc. | 2023-08-18 |
| P200TE (A10700) (K231673) | Optos Plc. | 2023-08-18 |
| IDS ACTH II (K223867) | Immunodiagnostic Systems Limited | 2023-08-18 |
| Automatic Continuous Effusion Shunt (ACES) System ACES System (K231096) | Pleural Dynamics, Inc. | 2023-08-18 |
| Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (K231777) | Olympus Winter & Ibe GmbH | 2023-08-18 |
| Dreem 3S (K223539) | Beacon Biosignals, Inc. | 2023-08-18 |
| Sterile Products of the APTUS System (K232144) | Medartis AG | 2023-08-18 |
| Onera Sleep Test System (Onera STS) (K223573) | Onera B.V. | 2023-08-18 |
| Feeding Tube (K222773) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| Xpert Xpress CoV-2/Flu/RSV plus (K231481) | Cepheid® | 2023-08-17 |
| Spirair Nasal Septal Strap (K223167) | Spirair, Inc. | 2023-08-17 |
| Aer-O-Scope Colonoscope System (K230588) | Gi View , Ltd. | 2023-08-17 |
| Tandry Locking Plate System (K230690) | Microware Precision Co., Ltd. | 2023-08-17 |
| Oral/Enteral Syringe with ENFit connector (K222772) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| Cadwell Guardian (K230415) | Cadwell Industries, Inc. | 2023-08-17 |
| EXTRON 5; EXTRON 7 (K230871) | DRTECH Corporation | 2023-08-17 |
| Integrity Implant (K223538) | Anika Therapeutics, Inc. | 2023-08-17 |
| InterCollagen® Guide (K223912) | Sigmagraft, Inc. | 2023-08-17 |
| SOMNUM (V.1.1.2.) (K223922) | Honeynaps Co., Ltd. | 2023-08-16 |
| Phototherapy System (OL-PDT950) (K230342) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-08-16 |
| Guided Surgery Kit (K231087) | Implant Direct Sybron Manufacturing, LLC | 2023-08-16 |
| Kyphoplasty Balloon Catheter (K223709) | Jiangsu Changmei Medtech Co., Ltd. | 2023-08-16 |
| Powdered Free Sterile Natural Rubber Latex Surgical Gloves (K230832) | The Egyptian Company For Medical & Electronic Industries | 2023-08-16 |
| Celsi Monitor (K230298) | Hadleigh Health Technologies | 2023-08-16 |
| Harvest Dental HD Gum Strip (K231389) | Harvest Dental Products, LLC | 2023-08-16 |
| CoreLink Navigation Instruments (K232116) | Corelink, LLC | 2023-08-16 |
| Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) (K230314) | New Era Medicare Sdn. Bhd. | 2023-08-16 |
| HemoScreen Hematology Analyzer (K222148) | Pixcell Medical Technologies, Ltd. | 2023-08-16 |
| Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) (K230577) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | 2023-08-16 |
| CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) (K232141) | Medtronic Sofamor Danek USA, Inc. | 2023-08-16 |
| TOPA12 Portable X-ray Unit (K230581) | Neuf, Inc. | 2023-08-16 |
| TA™ Stapler and Loading Unit with DST Series™ Technology (K231491) | Covidien | 2023-08-16 |
| AQUAbase nX (K223479) | B.Braun Medical, Inc. | 2023-08-16 |
| EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil (K232126) | Covidien | 2023-08-16 |
| Revi System (DEN220073) | Bluewind Medical , Ltd. | 2023-08-16 |
| BAROguard (K223874) | Paragonix Technologies | 2023-08-15 |
| Implant-One System (K231455) | Implant Logistics, Inc. | 2023-08-15 |
| primaLOK™ SP Interspinous Fusion System (K231807) | Wenzel Spine, Inc. | 2023-08-15 |
| Vscan Air (K231301) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-08-15 |
| Annalise Enterprise CTB Triage-OH (K231094) | Annalise-Ai Pty , Ltd. | 2023-08-15 |
| MA012 Aluminum wheelchair, MS019 steel wheelchair (K231750) | Sichuan Ast Medical Equipment Co., Ltd. | 2023-08-15 |
| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| 21HQ513D, 32HL512D, 31HN713D, 32HQ713D (K232127) | Lg Electronics.Inc | 2023-08-15 |
| Route 92 Medical Full Length 054 Access System (K231583) | Route 92 Medical, Inc. | 2023-08-15 |
| Xenix Medical Sacroiliac Fixation System (K231829) | Ht Medical D.B.A. Xenix Medical | 2023-08-15 |
| Organic cotton tampon, Viscose tampon (K231341) | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023-08-14 |
| ENDOGATOR™ Hybrid Irrigation Tubing (K231418) | Medivators | 2023-08-14 |
| Density (K230663) | Jeisys Medical, Inc. | 2023-08-14 |
| DESS Dental Smart Solutions (K231434) | Terrats Medical SL | 2023-08-14 |
| SaintView (K223660) | Inviz Corporation | 2023-08-14 |
| Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome (K232162) | Boston Scientific Corporation | 2023-08-14 |
| V-Laser (K231054) | Wontech Co., Ltd. | 2023-08-14 |
| SPICCA Cervical Fusion Cages (K230607) | Southern Medical (Pty) , Ltd. | 2023-08-14 |
| Stryker Resorbable Fixation System (K231208) | Stryker Leibinger GmbH & Co KG | 2023-08-14 |
| Yomi Robotic System (K231018) | Neocis, Inc. | 2023-08-14 |
| SPICCA Stand-Alone Cervical Fusion Cages (K230608) | Southern Medical (Pty) , Ltd. | 2023-08-14 |
| Electro-Spec Steri-Caps (K231905) | Electro-Spec, Inc. | 2023-08-14 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System (K232311) | L&K BIOMED Co., Ltd. | 2023-08-14 |
| Pulse Oximeter (K230172) | Beijing Choice Electronic Technology Co., Ltd. | 2023-08-12 |
| TK Pre-Filled Normal Saline Flush Syringe (K230756) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-12 |
| Pre-Filled Normal Saline Flush Syringe (K223584) | Anhui Tianyang Pharmaceutical Co., Ltd. | 2023-08-12 |
| Carex Hybrid Personal Lubricant (K223519) | Karex Industries Sdn. Bhd. | 2023-08-11 |
| PolyWear® Personal Protective Level 3 Gown (K230384) | PolyConversions, Inc. | 2023-08-11 |
| VersiHD with GuideMe software (K230632) | Nxstage Medical, Inc. | 2023-08-11 |
| NITINEX Memory Compression Staple (K231493) | Vilex, LLC | 2023-08-11 |
| NuEra Tight RF Family (K223856) | Bios S.R.L. | 2023-08-11 |
| eRapid Nebulizer System (K223840) | Pari Respiratory Equipment, Inc. | 2023-08-11 |
| PMT Expandable Cage (PMT EXP) (K230297) | Providence Medical Technology, Inc. | 2023-08-11 |
| Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (K231696) | Prevest Denpro Limited | 2023-08-11 |