| K233808 — LW Narrow Implant System | Ossvis Co., Ltd. Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241225 — Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241917 — EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233555 — AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | Philips Respironics Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233541 — ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240531 — SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | BioHorizons Implant Systems, Inc. Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240280 — Nano-Check RSV Test | Nano-Ditech Corporation Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241539 — Activmotion S | Newclip Technics Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240446 — Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241963 — WERAY | Picopack Co., Ltd. Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240326 — Solar Lumbar Interbody Fusion System | Degen Medical, Inc. Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242050 — Montage Settable Bone Putty | Orthocon, Inc. Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241912 — BIOCHARGE | Nanofiber Solutions, LLC Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241906 — BioBrace® Reinforced Implant | Conmed Corporation Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233723 — Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240359 — PowerGlide Pro Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241464 — ARx® SAI Implant System | Life Spine, Inc. Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. Mon Jul 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233725 — Spine Navigation System | Medivis, Inc. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241078 — Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240509 — STAR Apollo Mapping System | Rhythm AI, Ltd. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233994 — VOLT Proximal Humerus 3.5 Plating System | Synthes GmbH Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231776 — Cell-Free DNA BCT | Streck, Inc. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241187 — Alien Aligners | Alien Milling Technologies Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241494 — Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | Pro Med Instruments GmbH Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241898 — Symbia SPECT and SPECT/CT Systems | Siemens Healthineers Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241845 — Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233287 — Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241515 — NEXA NPWT System | Nexa Medical Limited Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241028 — Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Coloplast Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241866 — InnovaMatrix®FD | Convatec Triad Life Sciences, LLC Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233530 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) | DRTECH Corporation Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220328 — EasyStat 300 | Medica Corporation Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233501 — LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234131 — Resolv Endoscopic Hemostat System | Hemostasis, LLC Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241887 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) | Cosmo Artificial Intelligence - Ai, Ltd. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241864 — Grappler Interference Screw System | Paragon 28, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241171 — Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | Stryker Leibinger GmbH & Co KG Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233563 — Navident | Claronav, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241361 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241063 — s-Clean ScanHealing Abutment | Dentis Co., Ltd. Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233372 — KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |