| Corplex P / Theracor P / Allacor P (K231325) | Stimlabs, LLC | 2024-02-02 |
| PiXel8-Reveal (K233143) | Rohrer Aesthetics | 2024-02-02 |
| Myoaligner Appliance (K230548) | Myohealth Technologies, LLC | 2024-02-02 |
| Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) (K233756) | Rhein Laser Technologies Co., Ltd. | 2024-02-02 |
| 5008X Hemodialysis System (K231534) | Fresenius Medical Care | 2024-02-02 |
| CVAC Aspiration System + CVAC Image Processor (K233472) | Calyxo, Inc. | 2024-02-02 |
| Surgical Gown (40083) (K233183) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
| BTL-99-OC (K230657) | BTL Industries, Inc. | 2024-02-01 |
| Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles (K232165) | Berpu Medical Technology Co., Ltd. | 2024-02-01 |
| Resonic Rapid Acoustic Pulse Device (K233804) | Zeltiq Aesthetics, Inc. | 2024-02-01 |
| CAAS MR Solutions (K232007) | Pie Medical Imaging BV | 2024-02-01 |
| Augmented Reality Application (K232339) | Sira Medical, Inc. | 2024-02-01 |
| Kelowna GYN and Crook Prostate Templates (K232949) | Varian Medical Systems, Inc. | 2024-02-01 |
| WATCHMAN TruSteer Access System (M635TU90050) (K240018) | Boston Scientific Corporation | 2024-02-01 |
| Clearblue® Early Detection Pregnancy Test (K240025) | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 |
| CEPHX- Cephalometric Analysis Software (K231396) | Orca Dental AI , Ltd. | 2024-01-31 |
| CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer (K240004) | Circa Scientific, Inc. | 2024-01-31 |
| Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) (K233140) | Hygea Medical Technology Co., Ltd. | 2024-01-31 |
| MightySat -OTC (K214115) | Masimo Corporation | 2024-01-31 |
| “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (DEN210035) | Hologic, Inc. | 2024-01-31 |
| Digital Thermometer, Model T28, T28L (K232678) | Guangdong Genial Technology Co., Ltd. | 2024-01-31 |
| DermRays Revive (K231910) | Wuhan Lotuxs Technology Co., Ltd. | 2024-01-30 |
| VariTrax Sternal CircumFixation System (K232986) | Circumfix Solutions, Inc. | 2024-01-30 |
| Ziehm Vision FD (K240020) | Ziehm Imaging GmbH | 2024-01-30 |
| E3D™-A Interbody System (K232432) | Evolution Spine | 2024-01-30 |
| VIVA combo RF System (VIVA combo RF System) (K234140) | Starmed Co., Ltd. | 2024-01-30 |
| Redemption Duo Hindfoot Nail System (K231343) | Vilex, LLC | 2024-01-30 |
| G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media (K232942) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-01-30 |
| Rebuilder Nerve Guidance Conduit (K230794) | Celestray Biotech Company, LLC., | 2024-01-29 |
| Gem Flow Now (GEM2770-FN) (K233394) | Synovis Micro Companies Alliance | 2024-01-28 |
| Epilaser Pro (K233224) | Epilady 2000, LLC | 2024-01-27 |
| Perifit Pump (K231785) | X6 Innovations | 2024-01-26 |
| EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II (K232864) | Nantong Egens Biotechnology Co., Ltd. | 2024-01-26 |
| One-Fil (K232182) | Mediclus Co., Ltd. | 2024-01-26 |
| MONDRIAN™ Anterior Lumbar Plate System (K231715) | Ctl Medical Corporation | 2024-01-26 |
| iFuse Bedrock Granite® Implant System (K233508) | SI-BONE, Inc. | 2024-01-26 |
| Aptima Neisseria gonorrhoeae Assay (K231329) | Hologic, Inc. | 2024-01-26 |
| Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598) | Anhui Intco Medical Products Co., Ltd. | 2024-01-26 |
| Disposable Hemostatic Clips (K232450) | Zhejiang Soudon Medical Technology Co., Ltd. | 2024-01-26 |
| Ziehm Solo FD (K234109) | Ziehm Imaging GmbH | 2024-01-26 |
| CentriMag™ Acute Circulatory Support System (K234118) | ABBOTT MEDICAL | 2024-01-26 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (K231303) | Joytech Healthcare Co. , Ltd. | 2024-01-26 |
| LifeOutcomes C-Quest™ Blood Culture Sampling Device (K231282) | Lifeoutcomes, LLC | 2024-01-26 |
| ViSiGi 3D Gastric Sizing Tube (K234145) | Boehringer Laboratories | 2024-01-26 |
| Trigon Trigon HA Stand-Alone Wedge Fixation System (K234116) | Nvision Biomedical Technologies | 2024-01-26 |
| M-Wave (K233485) | Zynex Medical, Inc. | 2024-01-26 |
| ExactechGPS® System (K233299) | Blue Ortho | 2024-01-26 |
| AlphaVent Knotless SP PEEK Anchor (K233893) | Stryker Endoscopy | 2024-01-25 |
| MR Q; MR Q SUPINE; MR Q SLT (K232417) | Meridian AG | 2024-01-25 |
| GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) (K232665) | Convatec | 2024-01-25 |
| Facet Aurora Reusable Lancet Base (K232912) | Facet Technologies, LLC | 2024-01-25 |
| Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (K234127) | CooperVision, Inc. | 2024-01-25 |
| FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) (K233425) | Sutter Medizintechnik GmbH | 2024-01-25 |
| BreView (K233714) | GE Medical Systems SCS | 2024-01-25 |
| ADIRA™ Lateral Plate System (K233735) | Globus Medical, Inc. | 2024-01-25 |
| NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium (K233208) | Nobel Biocare AB | 2024-01-24 |
| Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (K231290) | The Binding Site, Ltd. | 2024-01-24 |
| Axial3D Cloud Segmentation Service (K231607) | Axial Medical Printing Limited | 2024-01-24 |
| Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System (K233195) | Canon Medical Systems Corporation | 2024-01-24 |
| Chemo Mouthpiece (K232917) | Chemo Mouthpiece, LLC | 2024-01-23 |
| Dental Glass Ceramics (K232673) | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 |
| SchurSign Tissue Marker (K230836) | Surgmark GmbH | 2024-01-23 |
| Nano-Check™ COVID-19 Antigen Test (K231187) | Nano-Ditech Corporation | 2024-01-23 |
| 2-Way 100% Silicone Cleartract Catheter (K233013) | Silq Technologies Corporation | 2024-01-23 |
| Endoform Dental Membrane (K231305) | Aroa Biosurgery , Ltd. | 2024-01-23 |
| Dental Porcelain Powder (K232676) | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 |
| Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) (K231423) | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-22 |
| NailLift (K230841) | Jps Corporation | 2024-01-22 |
| Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (K231299) | Cair Lgl | 2024-01-22 |
| IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) (K233887) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-01-22 |
| restor3d TIDAL Lumbar Interbody Fusion System (K234087) | Restor3D | 2024-01-22 |
| MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw (K233450) | Megagen Implant Co., Ltd. | 2024-01-22 |
| RESPONSE™ Rib and Pelvic System (K233105) | OrthoPediatrics Corp. | 2024-01-20 |
| EndoSign® Cell collection device (ES-CYT-102) (K233142) | Cyted Limited | 2024-01-19 |
| Plenity (K230133) | Gelesis, Inc. | 2024-01-19 |
| Power wheelchair (Model: JMPW-01W) (K232783) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2024-01-19 |
| MagnetOs Granules (K232347) | Kuros Biosciences B.V | 2024-01-19 |
| Electric Breast Pump, model: YM-8166 (K232466) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2024-01-19 |
| IlluminOss Photodynamic Bone Stabilization System (K233436) | Illuminoss Medical, Inc. | 2024-01-19 |
| Mix2Vial® Transfer Device (K231071) | West Pharma. Services IL, Ltd. | 2024-01-19 |
| BD Vacutainer® Fluoride Blood Collection Tubes (K231237) | Becton, Dickinson and Company | 2024-01-19 |
| Distal Access Catheter (K231218) | Accumedical Beijing , Ltd. | 2024-01-19 |
| DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (K231873) | Depuy Ireland UC | 2024-01-19 |
| LifeSPARC System (K233736) | Cardiacassist, Inc. | 2024-01-19 |
| Cold Compression Wrap Pro (K230524) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2024-01-19 |
| Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) (K233461) | Hi-Dow International, Inc. | 2024-01-19 |
| Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister (K232679) | Argon Medical Devices, Inc. | 2024-01-19 |
| TORPEDO Implant System® (K230817) | Deltacor GmbH | 2024-01-19 |
| Rapid ASPECTS (v3) (K232156) | Ischemaview, Inc. | 2024-01-19 |
| VerTouch Spinal Imaging Device (DEN220009) | Intuitap Medical, Inc. | 2024-01-19 |
| RIGHTEST Blood Glucose Monitoring System Max Tel (K231192) | Bionime Corporation | 2024-01-19 |
| SIGNA Champion (K233728) | Ge Healthcare (Tianjin) Company Limited | 2024-01-19 |
| HKT Anatomical Locking Trauma System (K231213) | Hankil Tech Medical Co., Ltd. | 2024-01-19 |
| Air Next (NVD-02) (K231416) | Nuvoair AB | 2024-01-18 |
| Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (K233242) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 |
| Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode (K231405) | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | 2024-01-18 |
| FlashHeal 2 (FlashHeal 2.0) (K233077) | Inwound Aps | 2024-01-18 |
| Radial Compression Device (K232577) | Ningbo Dizegens Medical Science Co.,Ltd | 2024-01-18 |
| ThinkQA (Edition 2) (K231573) | Dosisoft SA | 2024-01-18 |
| Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (K231166) | Zmi Electronics , Ltd. | 2024-01-18 |