| Avantik VTM (K233449) | Hanchang Medic Co., Ltd. (Han Chang Medic) | 2024-07-15 |
| CM00622 LINC Skin Closure System (CM00622 LINC) (K233460) | Connexicon Medical , Ltd. | 2024-07-15 |
| CM005 Standard (CM005); CM004 Mini (CM004) (K233458) | Connexicon Medical , Ltd. | 2024-07-15 |
| NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat (K241751) | Positrigo AG | 2024-07-15 |
| Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285) | Huxley Medical | 2024-07-15 |
| Omnifix Syringe NRFit (K241385) | B.Braun Medical, Inc. | 2024-07-13 |
| SPIRA® Anterior Lumbar Spacers (K234077) | Camber Spine Technologies | 2024-07-12 |
| Geistlich Bio-Oss® (K240661) | Geistlich Pharma AG | 2024-07-12 |
| Dental Glass Ceramics Blocks (HT,LT,ST) (K241715) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-07-12 |
| VersaCross Connect™ Transseptal Dilator (K241720) | Baylis Medical Company, Inc. | 2024-07-12 |
| S.I.N. Instrument Kits (K241378) | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-12 |
| Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K241500) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-07-12 |
| OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (K241707) | Unicon Optical Co., Ltd. | 2024-07-12 |
| Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (DEN220042) | Terragene S.A. | 2024-07-12 |
| Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) (K233644) | Megadyne Medical Products, Inc. | 2024-07-12 |
| BriefCase-Triage (K241727) | Aidoc Medical , Ltd. | 2024-07-12 |
| MRI Universal (K240651) | Stryker Leibinger GmbH & Co KG | 2024-07-12 |
| Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372) | Peters Surgical | 2024-07-12 |
| HemoCare Bicarbonate Concentrate Set (BCS) (K240920) | Deka Research and Development | 2024-07-12 |
| Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems (K240240) | Prismatik Dentalcraft, Inc. | 2024-07-12 |
| HemoCare Hemodialysis System (K233557) | Deka Research and Development | 2024-07-12 |
| Single Use Hemoclips (K234124) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 |
| “MoFi” Cell Culture Basal Medium (K240247) | Duogenic Stemcells Corporation | 2024-07-12 |
| RUS (K233457) | Hutom, Inc. | 2024-07-12 |
| KLS Martin Orthopedic Implants - MR Conditional (K241018) | KLS-Martin L.P. | 2024-07-12 |
| TMINI Miniature Robotic System (TMINI 1.1) (K241031) | THINK Surgical, Inc. | 2024-07-12 |
| Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (K241085) | Covidien, LLC | 2024-07-12 |
| Infinity Gateway Suite (K233834) | Draeger Medical Systems, Inc. | 2024-07-12 |
| HiRise (1040-230) (K241713) | Curvebeam, LLC | 2024-07-12 |
| MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) (K241705) | Milkmate Products, Inc. | 2024-07-12 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K234009) | Mighty Oak Medical | 2024-07-12 |
| Natural Cycles (K241006) | Natural Cycles Nordic AB | 2024-07-11 |
| Cytal® Wound Matrix; Cytal® Burn Matrix (K241724) | Acell, Inc. | 2024-07-11 |
| MicroMatrix® UBM Particulate (K241706) | Acell, Inc. | 2024-07-11 |
| SubtleSYNTH (1.x) (K241329) | Subtle Medical, Inc. | 2024-07-11 |
| Manual Wheelchair (K241460) | Lichtmega Technology Co., Ltd. | 2024-07-11 |
| tmCMF Solution (K233874) | Techmah Cmf | 2024-07-11 |
| Sterile single use tip cleaner (WK800-S10 , WK800-S20) (K241022) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2024-07-11 |
| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System; (K241000) | Depuy Ireland UC | 2024-07-11 |
| Drivewire 24 Guidewire (K233791) | Rapid-Medical , Ltd. | 2024-07-11 |
| CUSA® Clarity Ultrasonic Surgical Aspirator System (K240493) | Integra LifeSciences Corporation | 2024-07-11 |
| IPL Hair Removal Device (YT01,YT02,YT03,YT04) (K240016) | Shenzhen Jianrong Biomedical Electronics Co., Ltd. | 2024-07-10 |
| Lightin System, Lightin, Lightin Generator (K232177) | Solmedix Co., Ltd. | 2024-07-10 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (K240527) | Devicor Medical Products, Inc. | 2024-07-10 |
| Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask (K241661) | Sleepnet Corporation | 2024-07-10 |
| Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314 (K241683) | Boston Scientific Corporation | 2024-07-10 |
| GPS Advanced; 5 cc GPS Advanced Cannula (K241426) | Prosidyan, Inc. | 2024-07-10 |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) (K240666) | Medtronic Perfusion Systems | 2024-07-10 |
| AOS Interstitial Templates, Needles, and Accessories (K233628) | Alpha-Omega Services, Inc. | 2024-07-10 |
| Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (K240614) | Oticon Medical AB | 2024-07-10 |
| Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K241372) | ABBOTT MEDICAL | 2024-07-09 |
| OW100S (K233937) | Softwave/Trt, LLC | 2024-07-09 |
| IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) (K241343) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | 2024-07-09 |
| Prima Plus Conical Implant System (K240966) | Keystone Dental, Inc. | 2024-07-09 |
| deepLive (K240610) | Damae Medical | 2024-07-09 |
| Zirconia Block (K241316) | Hunan Hualian Special Ceramics Co., Ltd. | 2024-07-09 |
| EM-07 Cordless Endo Motor (K232551) | Forum Engineering Technologies (96) , Ltd. | 2024-07-09 |
| aprevo® TLIF-C Articulating System (K241019) | Carlsmed | 2024-07-09 |
| LED Light Therapy Device, ELIXIR MD™ (K241293) | Yassen Wellness, LLC | 2024-07-08 |
| da Vinci SP Surgical System (SP1098) (K240502) | Intuitive Surgical, Inc. | 2024-07-08 |
| RhythmStar System (K233584) | RhythMedix, LLC | 2024-07-08 |
| LifeRay Intraoral Handheld X-ray System (K241305) | Lucas Lifecare | 2024-07-05 |
| UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (K240252) | Beckman Coulter, Inc. | 2024-07-05 |
| AMT Suture Passer (K241111) | Applied Medical Technology, Inc. | 2024-07-05 |
| Anatase Navi Disposable Instrument (K241625) | Remex Medical Corp. | 2024-07-05 |
| DUO1 and DUO2 (K241649) | Zinnovi, Inc. | 2024-07-05 |
| SiOxD® Wound Matrix (K241660) | Sioxmed, LLC | 2024-07-05 |
| STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (K234082) | Advanced Sterilization Products | 2024-07-05 |
| Merlexi Craft Bariatric series of manual wheelchairs (K240120) | Turbo Wheelchair Co., Inc. | 2024-07-05 |
| STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (K234084) | Advanced Sterilization Products, Inc. | 2024-07-05 |
| Upper Arm Electronic Blood Pressure Monitor (K241129) | Shenzhen Goodlymed Technology Co., Ltd. | 2024-07-03 |
| ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) (K241629) | Ethicon Endo-Surgery, LLC | 2024-07-03 |
| SKOUT® system (K241508) | Iterative Scopes, Inc. | 2024-07-03 |
| Dermablate (K241600) | Asclepion Laser Technologies GmbH | 2024-07-03 |
| Iconix® Anchor (K241577) | Riverpoint Medical | 2024-07-03 |
| Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) (K241606) | Stryker Sustainability Solutions | 2024-07-03 |
| Transducer Probe Cover (K241615) | Hony Medical Co., Ltd. | 2024-07-03 |
| OSSIOfiber® Threaded Trimmable Fixation Nail (K241277) | OSSIO , Ltd. | 2024-07-03 |
| Blue Eye (K241591) | The Standard Co., Ltd. | 2024-07-03 |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (K241371) | Olympus Medical Systems Corporation | 2024-07-03 |
| Total Wrist Arthroplasty System (TWA) (K233574) | Skeletal Dynamics | 2024-07-03 |
| Disposable Enteral Feeding Sets (K240052) | Beijing L&Z Medical Technology Development Co., Ltd. | 2024-07-03 |
| Gastric Alimetry (K240946) | Alimetry , Ltd. | 2024-07-03 |
| da Vinci Surgical System (IS5000) (K241284) | Intuitive Surgical, Inc. | 2024-07-03 |
| Access Thyroglobulin Antibody II (K240996) | Beckman Coulter, Inc. | 2024-07-03 |
| iQFlex Pro (K240009) | First Source, Inc. | 2024-07-03 |
| Access sTfR (K240987) | Beckman Coulter, Inc. | 2024-07-03 |
| Extended Reservoir; MiniMed Reservoir (K241622) | Medtronic Minimed | 2024-07-02 |
| Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue (K240930) | Sri Trang Gloves Thailand (Public Company Limited) | 2024-07-02 |
| FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) (K232824) | Owens & Minor (O&M) Halyard, Inc. | 2024-07-02 |
| Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (K234083) | Balt USA, LLC | 2024-07-02 |
| AOS Marker Seeds (SMG0242-025) (K233626) | Alpha-Omega Services, Inc. | 2024-07-02 |
| SMART Bun-Yo-Matic X-Ray (K240736) | Disior, Ltd. | 2024-07-02 |
| Freedom® Total Knee System (K240863) | Maxx Orthopedics, Inc. | 2024-07-02 |
| Next Generation Access Catheter (K234074) | Balt USA, LLC | 2024-07-02 |
| ViewPoint 6 (K241300) | Ge Healthcare GmbH | 2024-07-02 |
| MagDI System (DEN240013) | Gt Metabolic Solutions, Inc. | 2024-07-02 |
| Fogarty Fortis Arterial Embolectomy Catheter (K241330) | Edwards Lifesciences | 2024-07-02 |