| Merge Hemo, Model RCSV2 (K233326) | Merge Healthcare Incorporated | 2024-06-21 |
| Therm-X (Home); Therm-X (AT) (K240125) | Zenith Technical Innovations | 2024-06-21 |
| MINAMO blue; MINAMO viola (K240387) | Asahi Intecc Co., Ltd. | 2024-06-21 |
| Medihub Prostate (K233196) | JLK, Inc. | 2024-06-21 |
| eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442) | Epic Medical Pte. , Ltd. | 2024-06-21 |
| Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) (K232807) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-21 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| See Factor CT3™ (K233230) | Epica International, Inc. | 2024-06-21 |
| Sunny Cup and Applicator (K233361) | Menstrual Mates | 2024-06-21 |
| Nimbl (model PD08-N1) (K234155) | Tactile Medical | 2024-06-21 |
| rainbow Paste Stain SE (K233885) | Genoss Co., Ltd. | 2024-06-21 |
| PRESSUREALERT® Pressure Monitoring System (K233096) | Position Health, LLC | 2024-06-21 |
| GERDX-System (K233240) | G-Surg GmbH | 2024-06-21 |
| Pulse Oximeter (MD300C228) (K232975) | Beijing Choice Electronic Technology Co., Ltd. | 2024-06-21 |
| Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) (K240663) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-06-21 |
| Medicom Sterilization Wrap (K240862) | Medicom Group, Inc. | 2024-06-21 |
| Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (K233117) | Nakanishi, Inc. | 2024-06-20 |
| RODIN Titan 3D Resin (K240688) | Belport Company, Inc., Gingi-Pak | 2024-06-20 |
| Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue (K241435) | Smith & Nephew, Inc. | 2024-06-20 |
| IVYLASER Diode laser hair removal system (IVY-HR-Alloy) (K240611) | Ivylaser (Beijing) Technology Co.,Ltd | 2024-06-20 |
| Electric wheelchair (K240673) | Zhejiang Hfizer Medical Equipment Co., Ltd. | 2024-06-20 |
| Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System (K241466) | SeaSpine Orthopedics Corporation | 2024-06-20 |
| APTUS Elbow Dorsal Olecranon Plates (K240613) | Medartis AG | 2024-06-20 |
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K230675) | Specific Diagnostics, LLC | 2024-06-20 |
| DeepRhythm Platform (K232161) | Medicalgorithmics S.A. | 2024-06-20 |
| Freedom Peripheral Nerve Stimulator (PNS) System (K233162) | Curonix | 2024-06-20 |
| SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) (K233225) | Schoelly Fiberoptic GmbH | 2024-06-20 |
| Safety Lancet (XXXV) (K241627) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 |
| Copra Smile, Copra Supreme Hyperion (K233158) | Whitepeaks Dental Solutions GmbH | 2024-06-20 |
| Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (K240830) | Orthofix Medical, Inc. | 2024-06-20 |
| ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System (K240669) | Globus Medical, Inc. | 2024-06-20 |
| SMART Bun-Yo-Matic CT (K240642) | Disior, Ltd. | 2024-06-20 |
| EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 (K232997) | Olympus Medical Systems Corporation | 2024-06-19 |
| Invisalign System (K241412) | Align Technology, Inc. | 2024-06-18 |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K240678) | Depuy Ireland UC | 2024-06-18 |
| Pen Injector (K240774) | Wuxi Nest Biotechnology Co., Ltd. | 2024-06-18 |
| Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) (K240196) | Yuwonmeditech Co., Ltd. | 2024-06-18 |
| MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (K233553) | Thayer Medical Corporation | 2024-06-18 |
| Ultrasonic Surgical System (K233036) | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2024-06-18 |
| IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) (K240583) | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | 2024-06-18 |
| Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM (K233294) | Itp Innovative Tomography Products GmbH | 2024-06-18 |
| Fitbone Trochanteric (K233867) | Orthofix Srl | 2024-06-18 |
| Irrisept Antimicrobial Wound Lavage (K240552) | Irrimax Corporation | 2024-06-18 |
| VERABAND™ (K233987) | Arbor Medical Innovations, LLC | 2024-06-17 |
| AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (K241428) | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 |
| Molecular Transport Media - MTM (K233324) | Alb Luz | 2024-06-17 |
| XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (K232258) | Transit Scientific, LLC | 2024-06-17 |
| Robotic Integration Instruments (K233256) | DePuy Synthes | 2024-06-17 |
| Elecsys Folate III (K233060) | Roche Diagnostics | 2024-06-17 |
| MediOMx (K233331) | Pmx, Inc. | 2024-06-17 |
| Medical Diode Laser (M2-GK) (K240747) | Wuhan Pioon Technology Co., Ltd. | 2024-06-17 |
| CROSSNAV Navigation Enabled Instruments (K233255) | DePuy Synthes | 2024-06-17 |
| Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System (K240684) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-06-17 |
| Ion 3D (K241416) | SurGenTec, LLC | 2024-06-17 |
| Multi-parameter detector (K231116) | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024-06-15 |
| iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask (K241469) | Sleepnet Corporation | 2024-06-15 |
| ExcelsiusFlex™ (K240721) | Globus Medical, Inc. | 2024-06-14 |
| Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) (K233079) | Cook Ireland, Ltd. | 2024-06-14 |
| 3DMax Light Mesh (K241250) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 |
| TELIGEN System Navigation Ready Instruments (K233254) | DePuy Synthes | 2024-06-14 |
| INNOVERSE Navigation Instruments (K241082) | Innosys Co., Ltd. | 2024-06-14 |
| Airdog X8 Air Purifier (KJ800F-X8) (K240696) | Suzhou Beiang Smart Technology Co., Ltd. | 2024-06-14 |
| SIS System (K241083) | Surgical Information Sciences, Inc. | 2024-06-14 |
| Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) (K240729) | Shenzhen Pango Medical Electronics Co., Ltd. | 2024-06-14 |
| Spine Navigation and Robotic-Assistance Device (K233228) | Ecential Robotics | 2024-06-14 |
| HFT150 (K233707) | Invent Medical Corporation | 2024-06-14 |
| CanGaroo RM Antibacterial Envelope (K233991) | Elutia, Inc. | 2024-06-14 |
| VersaWrap (K240817) | Alafair Biosciences, Inc. | 2024-06-14 |
| Disposable High-pressure Extension Lines (K230668) | Precision Medical Plastics , Ltd. | 2024-06-14 |
| Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) (K232893) | Contec Medical Systems Co.,Ltd | 2024-06-14 |
| Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) (K232812) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-14 |
| EndeavorOTC (K233496) | Akili Interactive Labs, Inc. | 2024-06-14 |
| Smart Scope® CX (K233043) | Periwinkle Technologies Pvt., Ltd. | 2024-06-14 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
| Air Pressure Therapy System (Model:VU-IPC4M) (K233238) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-06-14 |
| G-Vitri™ Vitrification Straw (K240002) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-14 |
| BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (K240124) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 |
| Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (K241407) | Bios S.R.L. | 2024-06-14 |
| Clarius OB AI (K233955) | Clarius Mobile Health Corp. | 2024-06-14 |
| VERVE (K232930) | Oculomotor Technologies | 2024-06-13 |
| Double Balloon Endoscope EN-840T, Over-tube TS-1214C (K233321) | FUJIFILM Healthcare Americas Corporation | 2024-06-13 |
| Relu Creator (K233925) | Relu BV | 2024-06-13 |
| ProMin Dental Desensitizing Gel (K231060) | Belport Company, Inc., Gingi-Pak | 2024-06-13 |
| 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) (K233892) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024-06-13 |
| InMode System with the Morpheus8 90 Applicator (K240017) | InMode , Ltd. | 2024-06-13 |
| F&P Optiflow Oxygen Kit (AA451J) (K233821) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
| Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium (K240149) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-13 |
| AquaBplus; AquaB LITE (K232953) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 |
| FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) (K240460) | FMD Co., Ltd. | 2024-06-13 |
| Radiography 7300 C (K233662) | Philips Medical Systems Dmc GmbH | 2024-06-13 |
| BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E (K241358) | Sun Pharmaceutical Industries, Inc. | 2024-06-13 |
| 21.3” 5MP Color LCD Display UMD5-21B01 (K241499) | Acula Technology Corp. | 2024-06-13 |
| Arthrex Cannulated Screw System (K240815) | Arthrex, Inc. | 2024-06-13 |
| Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) (K241370) | ABBOTT MEDICAL | 2024-06-13 |
| Identity Shoulder System (K240876) | Zimmer, Inc. | 2024-06-12 |
| ACUSON SC2000 Diagnostic Ultrasound System (K233613) | Siemens Medical Solutions USA, Inc. | 2024-06-12 |
| VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967) | bioMerieux, Inc. | 2024-06-12 |
| Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (K241034) | Medacta International S.A. | 2024-06-12 |
| RS85 Diagnostic Ultrasound System (K240516) | Samsung Medison Co., Ltd. | 2024-06-12 |
| Remunity System (K240256) | Deka Research and Development | 2024-06-12 |