| K243595 — OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. Dec 19, 2024 |
| K243725 — BD Vaginal Panel | Becton, Dickinson And Company Dec 19, 2024 |
| K242467 — IQ-UIP | Imbio, Inc. Dec 19, 2024 |
| K232813 — Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda Dec 19, 2024 |
| K243171 — Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. Dec 19, 2024 |
| K241168 — System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. Dec 19, 2024 |
| K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific Dec 19, 2024 |
| K241322 — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co. , Ltd. Dec 19, 2024 |
| K242270 — OrthoNext Platform System | Orthofix Srl Dec 19, 2024 |
| K242063 — LibAirty Airway Clearance System | Synchrony Medical , Ltd. Dec 19, 2024 |
| K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. Dec 19, 2024 |
| K242819 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Dec 19, 2024 |
| K240885 — Shadow Catheter | Simpson Interventions, Inc. Dec 19, 2024 |
| K240348 — Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. Dec 19, 2024 |
| K243705 — Saige-Density (2.5.0) | DeepHealth, Inc. Dec 19, 2024 |
| K243094 — Quickdent Dental Implant System | Quickdent Devices Private , Ltd. Dec 19, 2024 |
| K241778 — Hudson RCI Comfort Flo® CubCannula | Medline Industries, LP Dec 19, 2024 |
| K242892 — Cristaline Aligners Z FLX | Cristaline Aligners GmbH Dec 19, 2024 |
| K243430 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. Dec 19, 2024 |
| K241395 — Active System; Avenue8 | Caerus Corporation Dec 18, 2024 |
| K243615 — Physica Porous Femoral Components | Lima Corporate S.P.A. Dec 18, 2024 |
| K240959 — Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. Dec 18, 2024 |
| K242216 — GENTAFIX® (1, 3, 3MV) | Teknimed Sas Dec 18, 2024 |
| K241095 — ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps Dec 18, 2024 |
| K242787 — Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. Dec 18, 2024 |
| K242424 — Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. Dec 18, 2024 |
| K241040 — Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. Dec 18, 2024 |
| K243720 — 3Delta UNlimited | Deltamed GmbH Dec 18, 2024 |
| K243625 — Xpert MRSA/SA SSTI | Cepheid® Dec 18, 2024 |
| K243128 — Klockner Kits | SOADCO, S.L. Dec 18, 2024 |
| K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. Dec 18, 2024 |
| K243609 — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | Etex Corporation Dec 18, 2024 |
| K240765 — Porous Biologic Scaffold | Ventris Medical Dec 18, 2024 |
| K240763 — FirstFit Surgical Kit | Freudenberg Medical, LLC Dec 18, 2024 |
| K241058 — Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. Dec 18, 2024 |
| K241132 — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps Dec 18, 2024 |
| K242662 — Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. Dec 18, 2024 |
| K241036 — Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. Dec 17, 2024 |
| K242413 — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Vizionfocus, Inc. Dec 17, 2024 |
| K242815 — POCKET TENS (EP-300) | Hivox Biotek, Inc. Dec 17, 2024 |
| K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific,, LLC Dec 17, 2024 |
| K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH Dec 17, 2024 |
| K242987 — Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited Dec 17, 2024 |
| K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. Dec 17, 2024 |
| K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Limited Dec 17, 2024 |
| K240798 — Cntrl+ Bladder Support Pessary | Cntrl+, Inc. Dec 17, 2024 |
| K242558 — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. Dec 17, 2024 |
| K243336 — Lucitone Digital Print Denture System | Dentsply Sirona, Inc. Dec 17, 2024 |
| K242816 — Quantium | Bisco, Inc. Dec 17, 2024 |
| K241801 — Tornus ES | Asahi Intecc Co., Ltd. Dec 17, 2024 |