| Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (K240257) | Bd | 2024-02-29 |
| NPseal (Small, Medium, Large) (K240244) | Guard Medical, Inc. | 2024-02-29 |
| APRO 55 Catheter and Alembic Aspiration Tubing (K232971) | Alembic, LLC | 2024-02-29 |
| Curiteva Thoracolumbar Plate System (K233360) | Curiteva, Inc. | 2024-02-29 |
| Accu-Joint Hemi Implant (K240268) | Accufix Surgical, Inc. | 2024-02-29 |
| inHEART Models (K231683) | Inheart, Sas | 2024-02-29 |
| Dental unit Model: Mare (K231845) | Foshan Safety Medical Equipment Co., Ltd. | 2024-02-28 |
| Dawn Diode Laser System (K232885) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-02-28 |
| OsteoCool™ 2.0 RF Ablation System (K233830) | Medtronic Sofamor Danek USA, Inc. | 2024-02-28 |
| PowerWire Radiofrequency Guidewire Kit (K232562) | Baylis Medical Technologies, Inc. | 2024-02-28 |
| Intra.Ox™ 2.0 Handheld Tissue Oximeter (K233488) | Vioptix, Inc. | 2024-02-28 |
| CT Cardiomegaly (K232613) | Innolitics, LLC | 2024-02-28 |
| Technozym ADAMTS13 Activity (DEN230024) | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | 2024-02-28 |
| Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (K233879) | Maquet Cardiovascular, LLC | 2024-02-27 |
| Camber Sacroiliac (SI) Fixation System (K233972) | Camber Spine Technologies | 2024-02-27 |
| Peace N Quiet (0.7.0) (K233435) | Pnq Health | 2024-02-27 |
| ARK Levetiracetam II Assay (K232522) | Ark Diagnostics, Inc. | 2024-02-27 |
| 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM (K232607) | Solco Biomedical Copany India Private Limited | 2024-02-27 |
| Praxiject™ SP 0.9% NaCl (K233623) | Medxl, Inc. | 2024-02-27 |
| Obsidian® NOW (K234014) | Prismatik Dentalcraft, Inc. | 2024-02-27 |
| Coresculpt & Magsculpt (K222400) | K1Med Co., Ltd. | 2024-02-27 |
| Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (K233560) | Eco Medi Glove Sdn. Bhd. | 2024-02-26 |
| VADER® Pedicle System (K232628) | Icotec AG | 2024-02-26 |
| FMS VUE™ Fluid Management and Tissue Debridement System (K233675) | DePuy Mitek, Inc. | 2024-02-26 |
| Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) (K232752) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-26 |
| BIS™ Advance Monitoring System (K230693) | Covidien, LLC | 2024-02-26 |
| GOLFF Sterile Anti-Fog Solution (K231822) | Batrik Medical Manufacturing, Inc. | 2024-02-26 |
| TENS device-HeadaTerm 2 (Model: YF-HT2) (K230782) | Wat Medical Technology, Inc. | 2024-02-26 |
| Dexcom G7 Continuous Glucose Monitoring System (K234133) | Dexcom, Inc. | 2024-02-26 |
| Stellaris Elite vision enhancement system (K232084) | Bausch and Lomb | 2024-02-26 |
| Iconix Knotless Anchor (K240213) | Riverpoint Medical | 2024-02-23 |
| Lymphedema Compression (K240011) | Jkh Health Co., Ltd. | 2024-02-23 |
| Ivotion Base Print (K233995) | Ivoclar Vivadent, Inc. | 2024-02-23 |
| Navigation Tracking Instruments (K232800) | SI-BONE, Inc. | 2024-02-23 |
| rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono (K232174) | Genoss Co., Ltd. | 2024-02-23 |
| ENSO (Model 2) (K233784) | Hinge Health, Inc. | 2024-02-23 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated (K240190) | Medtronic | 2024-02-23 |
| StatStrip Glucose Hospital Meter System (K232075) | Nova Biomedical Corporation | 2024-02-23 |
| Electronic Peak Flow Meter (K230423) | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 |
| PathLoc SI Joint Fusion System (K240201) | L&K BIOMED Co., Ltd. | 2024-02-23 |
| Soldier Microcatheter (K232536) | Embolx, Inc. | 2024-02-23 |
| AIO Breathe (K233754) | Aiomega, LLC | 2024-02-23 |
| MIRA Surgical System (DEN230025) | Virtual Incision | 2024-02-23 |
| COGNiTiON™ Staple System (K240212) | Ortho Solutions UK , Ltd. | 2024-02-23 |
| Overjet Charting Assist (K233590) | Overjet, Inc. | 2024-02-23 |
| Exceed Unlimited (K233709) | Mt. Derm GmbH | 2024-02-23 |
| Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) (K233576) | Shenzhen Konmed Technology Co., Ltd. | 2024-02-23 |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System (K231679) | Ascensia Diabetes Care | 2024-02-23 |
| RADspeed Pro (K233722) | Shimadzu Corporation | 2024-02-23 |
| FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (K231601) | Sebia | 2024-02-23 |
| Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card (K232228) | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 |
| Oligio X (K240313) | Wontech Co., Ltd. | 2024-02-22 |
| Treace Medical Systems (TMC) Plating System (K240173) | Treace Medical Concepts, Inc. | 2024-02-22 |
| R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) (K240193) | Sorin Group Italia S.R.L. | 2024-02-22 |
| Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (K214037) | Ergo-Flex Technologies, LLC | 2024-02-22 |
| MESHEET (K233544) | Dentis Co., Ltd. | 2024-02-22 |
| Revolution Ascend Sliding (K233749) | Ge Hangwei Medical Systems Co., Ltd. | 2024-02-22 |
| NanoDrop Lancet (K223826) | Drawbridge Health, Inc. | 2024-02-22 |
| MultiPulse HoPLUS (K231876) | Asclepion Laser Technologies GmbH | 2024-02-22 |
| Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (K233640) | Alphatec Spine, Inc. | 2024-02-22 |
| Vaginal Tactile Ultrasound Imager (K231875) | Advanced Tactile Imaging, Inc. | 2024-02-22 |
| Serafin® (K232074) | Tns Co., Ltd. | 2024-02-22 |
| Vivatmo pro (K233775) | Bosch Healthcare Solutions GmbH | 2024-02-22 |
| Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle (K232163) | Zhejiang Horizon Medical Technology Co., Ltd. | 2024-02-22 |
| Quiver Aspiration Pump (K232831) | Anoxia Medical, Inc. | 2024-02-22 |
| 1688 4K Camera System with Advanced Imaging Modality (K240174) | Stryker Endoscopy | 2024-02-22 |
| Ulthera System (UC-1 Control Unit PRIME) (K233996) | Ulthera, Inc. | 2024-02-22 |
| X-Guide Surgical Navigation System (K232148) | X-Nav Technologies, LLC | 2024-02-21 |
| ROSA® Shoulder System (K233199) | Orthosoft Inc (D/B/A Zimmer Cas) | 2024-02-21 |
| HD60 Series Ultrasound Diagnostic System (K233439) | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-02-21 |
| BLUEPRINT™ Patient Specific Instrumentation (K232265) | Tornier S.A.S. | 2024-02-21 |
| BraidE Embolization Assist Device (DEN230064) | Rapid Medical Ltd. | 2024-02-21 |
| Pulmonary Function Tester, Model: A9 (K231561) | Guangzhou Homesun Medical Technology Co., Ltd. | 2024-02-21 |
| Oneday Implant Abutment (K231753) | Oneday Biotech Co., Ltd. | 2024-02-21 |
| ProCinch, QuadCinch (K240194) | Riverpoint Medical | 2024-02-21 |
| Cocoon Convective Warming System, Model CWS7000 (K232502) | Care Essentials Pty, Ltd. | 2024-02-21 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (K233325) | Visionary Optics, LLC | 2024-02-21 |
| Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (K233471) | Stryker Sustainability Solutions | 2024-02-20 |
| TS Abutment System (K233194) | Osstem Implant Co., Ltd. | 2024-02-20 |
| Diode Laser Therapy System (K231896) | Beijing Adss Development Co., Ltd. | 2024-02-20 |
| Mjolnir Pro. (Multi–electrode plasma) (K233760) | Shenzhen Leaflife Technology Co., Ltd. | 2024-02-20 |
| NET BRAND Osteosynthesis Nailing System (K233150) | Narang Medical , Ltd. | 2024-02-20 |
| ONLINE TDM Methotrexate (K233454) | Roche Diagnostics Operations | 2024-02-20 |
| BD Prevue™ II Peripheral Vascular Access System (K240146) | Bard Access Systems, Inc. | 2024-02-18 |
| Oral Matrix (K231513) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024-02-16 |
| AGILON® XO Shoulder Replacement System (K231657) | Implantcast GmbH | 2024-02-16 |
| Airgle Room Air Purifier (K232645) | Airgle Corporation | 2024-02-16 |
| Disposable Grounding Pad (K231985) | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-02-16 |
| Dental LT Comfort Resin (K232087) | Formlabs Ohio, Inc. | 2024-02-16 |
| NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) (K233708) | Synaptic Medical Corporation | 2024-02-16 |
| Medline Luer Lock Syringes (K230235) | Medline Industries, LP | 2024-02-16 |
| S-Patch (S-Patch ExL) (K233906) | Wellysis Corp. | 2024-02-16 |
| Montage Flowable Settable, Resorbable Bone Paste (K232771) | Orthocon, Inc. | 2024-02-16 |
| Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (K240137) | Neos Surgery S.L | 2024-02-16 |
| Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) (K232043) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-16 |
| Access CK-MB (K234005) | Beckman Coulter, Inc. | 2024-02-16 |
| SCIg60 Infusion System (K240148) | Emed Technologies Corporation | 2024-02-16 |
| Zenition 30 (K232420) | Philips Medical Systems Nederland B.V. | 2024-02-16 |
| Biowy Tym Tube (TT) (K233658) | Biowy Corporation | 2024-02-16 |
| SnapHammer Hammertoe Correction System (K231453) | Nvision Biomedical Technologies, Inc. | 2024-02-16 |