| Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (K213652) | Cresilon, Inc. | 2023-06-28 |
| Curiteva Laminoplasty System (K231232) | Curiteva, Inc. | 2023-06-28 |
| e-Celsius Medical System (K210924) | Bodycap | 2023-06-28 |
| MIO Blood Glucose Monitoring System (K223722) | Mio Labs, Inc. | 2023-06-28 |
| Aneroid Sphygmomanometer (K230859) | Wenzhou Kangshun Medical Devices Co.,Ltd | 2023-06-28 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K (K230075) | Microlife Intellectual Property GmbH | 2023-06-28 |
| Medi Lift PLUS (K220198) | Ya-Man, Ltd. | 2023-06-28 |
| AceConnex Pre-Sutured Fascia (K213046) | Allosource | 2023-06-27 |
| RI.KNEE Adjustable Tibia Cut Guide (K230876) | Enztec Limited | 2023-06-27 |
| Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) (K231124) | Owen Mumford, Ltd. | 2023-06-27 |
| Hope&Her Vaginal Dilators (K222492) | Lujena, Inc. | 2023-06-27 |
| Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) (K223100) | Medline Industries, Inc. | 2023-06-27 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K231636) | L&K BIOMED Co., Ltd. | 2023-06-27 |
| VADER® Pedicle System Navigated Instruments (K230861) | Icotec AG | 2023-06-27 |
| EMBOLD™ Soft Detachable Coil System (K230706) | Boston Scientific Corporation | 2023-06-27 |
| NobelZygoma PureSet™ Tray (K231219) | Nobel Biocare Services AG | 2023-06-27 |
| SAGICO Spinal System (K223143) | Sagico VA USA, LLC | 2023-06-26 |
| ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) (K230914) | ArthroCare Corporation | 2023-06-26 |
| Bone Bolt System (K230867) | University of Utah, Department of Orthopaedics | 2023-06-26 |
| Z7 Zirconia Implant System (K221488) | Z7, LLC | 2023-06-26 |
| VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (K222378) | bioMerieux, Inc. | 2023-06-26 |
| Avitus® Precision Autograft Delivery System (K230492) | Avitus Orthopaedics, Inc. | 2023-06-26 |
| AB1 Electrosurgical Instrument, Creo Electrosurgical System (K223138) | Creo Medical, Ltd. | 2023-06-26 |
| IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S (K231215) | Zhongshan Qizhe Technology Co., Ltd. | 2023-06-26 |
| BR SLA Type Implant System (K222142) | Biotem Co., Ltd. | 2023-06-24 |
| Neuhat Hair Growth System; ibeauty.com Laser Cap (K231153) | Nature, Inc.redible, Inc. | 2023-06-23 |
| neXus Ultrasonic Surgical Aspirator System (K231117) | Misonix, LLC, A Bioventus Company | 2023-06-23 |
| EUROPA™ Navigated Instruments (K230369) | MiRus, LLC | 2023-06-23 |
| Virtus Metabolic Monitor (K222982) | Virtus Technology Aps | 2023-06-23 |
| Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) (K230036) | Rti Surgical, Inc. | 2023-06-23 |
| Hudson RCI Variable concentration Large Volume Nebulizer (1770) (K220955) | Medline Industires, Inc. | 2023-06-23 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| DD medical polymers (PMMA) (K230410) | Dental Direkt GmbH | 2023-06-23 |
| KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- (K230359) | Karl Storz Endoscopy America, Inc. | 2023-06-23 |
| AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592) | Encore Medical L.P. | 2023-06-23 |
| Radixact Treatment Delivery System (K223159) | Accuray Incorporated | 2023-06-23 |
| Neodent Implant System - Helix Short Implant System (K223638) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-06-23 |
| Medisystem Pacs (K223048) | Medilab Manutencao E Sitemas Ltda | 2023-06-23 |
| VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E (K230160) | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-23 |
| HydraDose Vaginal Suppositories (K230518) | MD Labs, LLC | 2023-06-23 |
| MapRT (K231185) | Vision Rt, Ltd. | 2023-06-23 |
| AccurECG Analysis System (K223013) | Accurkardia, Inc. | 2023-06-23 |
| ActiGraph LEAP activity monitor (ActiGraph LEAP) (K231532) | Actigraph, LLC | 2023-06-23 |
| FERTI-LILY Conception Cup (K222969) | Rosesta Medical BV | 2023-06-23 |
| Mais Central Venous Catheter (K221827) | Saudi Mais Co. For Medical Products | 2023-06-23 |
| Surflo Winged Infusion Set (K221411) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2023-06-23 |
| HemosIL Liquid Anti-Xa (K223187) | Instrumentation Laboratory CO | 2023-06-23 |
| TECHFIT DISRP® System (K230276) | Techfit Digital Surgery | 2023-06-23 |
| PERLA® TL System; TEKTONA® HV US Bone Cement (K230774) | Spineart | 2023-06-23 |
| Black Diamond (K222323) | Elevate Oral Care, LLC | 2023-06-23 |
| sam 2.0 Long Ultrasound Device (K223019) | ZetrOZ Systems, LLC | 2023-06-23 |
| Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) (K223741) | Zhuhai Pusen Medical Technology Co., Ltd. | 2023-06-22 |
| Portable Oxygen Concentrator (Model: P2-E7, P2-E) (K223379) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-06-22 |
| Diode Laser Body Sculpture Systems (K231131) | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 |
| SelectFlex Neurovascular Access System Family (K230322) | Q'Apel Medical, Inc. | 2023-06-22 |
| Arthrex Virtual Implant Positioning (VIP) System (K230904) | Arthrex, Inc. | 2023-06-22 |
| Straumann SLActive labeling changes (K223083) | Institut Straumann AG | 2023-06-22 |
| TargetCool™ (K230599) | Recensmedical, Inc. | 2023-06-22 |
| Miria Skin Treatment System (K223871) | AVAVA, Inc. | 2023-06-22 |
| INVOcell Intravaginal Culture System (K222932) | Invo Bioscience | 2023-06-22 |
| Talee, Talee PostOp (K230444) | Invent Medical USA, LLC | 2023-06-22 |
| QuickRayPRO (K231202) | Denterprise International, Inc. | 2023-06-22 |
| Bladder AI (AIBV01) (K230497) | Exo, Inc. | 2023-06-22 |
| CUVIS-spine (K223558) | Curexo, Inc. | 2023-06-22 |
| da Vinci E-200 Electrosurgical Generator (K231212) | Intuitive Surgical | 2023-06-21 |
| Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K230886) | Stryker Endoscopy | 2023-06-21 |
| iLet® ACE Pump (K231485) | Beta Bionics, Inc. | 2023-06-21 |
| Sturdy Autoclave Super Microm (K231489) | Sturdy Industrial Co., Ltd. | 2023-06-21 |
| PAXgene® Blood DNA Tube (K231469) | Preanalytix GmbH | 2023-06-21 |
| Tablo® Hemodialysis System (K223248) | Outset Medical, Inc. | 2023-06-21 |
| PureLift Pro Edition (K230506) | Xtreem Pulse | 2023-06-21 |
| Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (K230309) | Centerline Biomedical, Inc. | 2023-06-21 |
| ACL TOP Family 70 Series (K231031) | Instrumentation Laboratory Company | 2023-06-21 |
| Accurate 24 Non-invasive blood pressure monitor (K222658) | Accurate Meditech, Inc. | 2023-06-21 |
| Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) (K223376) | Cardinal Health200, LLC | 2023-06-21 |
| 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF (K231467) | Rayence Co., Ltd. | 2023-06-21 |
| Tixel® 2 System (K223033) | Novoxel , Ltd. | 2023-06-21 |
| Habib EndoHPB (K231533) | Boston Scientific Corporation | 2023-06-21 |
| Antibacterial Bandage (K221311) | Winner Medical Co., Ltd. | 2023-06-21 |
| tremoflo C2 Airwave Oscillometry System (K221024) | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| SMARTbase Abutment System (K223535) | Implant Direct Sybron Manufacturing, LLC | 2023-06-20 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| Belle Sensilube (K230781) | Rb Health (Us), LLC | 2023-06-20 |
| ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (K231148) | Vvt Medical , Ltd. | 2023-06-20 |
| NC° Thermometer (Gen 3), Model Number: NCTG3 (K223522) | Xiamen Intretech, Inc. | 2023-06-20 |
| F3 (K222998) | Acrew Imaging, Inc. | 2023-06-20 |
| BethaLoc® stem cementless HA (K223103) | Implantcast GmbH | 2023-06-20 |
| CODA™ Anterior Cervical Plate System (K230993) | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | 2023-06-20 |
| HepaFatSmart (V2.0.0) (K231459) | Resonance Health Analysis Services Pty, Ltd. | 2023-06-20 |
| Sparrow Ascent (K230796) | Spark Biomedical, Inc. | 2023-06-20 |
| Perfit CL (K223029) | Vatech Mcis Co., Ltd. | 2023-06-20 |
| Voluson SWIFT; Voluson SWIFT+ (K230346) | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | 2023-06-20 |
| Sinobot X1 (K220072) | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 |
| VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P (K223917) | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-17 |
| VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P (K223920) | Vinno Technology (Suzhou) Co.,Ltd | 2023-06-17 |
| NAJA Gastrointestinal Catheter (K223890) | Chess Medical, Inc. | 2023-06-16 |
| Solar Lumbar Interbody Fusion System (K231199) | Degen Medical | 2023-06-16 |
| Healgen URS Test Strips (K231045) | Healgen Scientific,, LLC | 2023-06-16 |
| Volumat Polyethylene I.V. Administration Set (K221121) | Fresenius Kabi | 2023-06-16 |
| Zynex Monitoring System, Model CM-1600 (K223217) | Zynex Medical, Inc. | 2023-06-16 |