510(k) Clearances — Page 126
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242046 — EXULT Knee Replacement System | Corentec Co., Ltd. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241140 — ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | Pentax of America, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233696 — DePuy Synthes Retrograde Femoral Nail Advanced System | DePuy Synthes Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241690 — Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241137 — Clear Moves Aligner | Clear Moves Aligners Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233808 — LW Narrow Implant System | Ossvis Co., Ltd. Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240967 — ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT 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) |
| K241934 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | Anx Robotica Corp Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240898 — SteriTite rigid reusable sterilization container with MediTray Products | Case Medical 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) |
| K233541 — ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. Wed Jul 31 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) |
| K240280 — Nano-Check RSV Test | Nano-Ditech Corporation Tue Jul 30 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) |
| K241539 — Activmotion S | Newclip Technics 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) |
| K241906 — BioBrace® Reinforced Implant | Conmed Corporation 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) |
| K241912 — BIOCHARGE | Nanofiber Solutions, LLC 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) |
| 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) |
| K234131 — Resolv Endoscopic Hemostat System | Hemostasis, LLC 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) |
| K241866 — InnovaMatrix®FD | Convatec Triad Life Sciences, LLC Fri Jul 26 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) |
| K240509 — STAR Apollo Mapping System | Rhythm AI, 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) |
| K231776 — Cell-Free DNA BCT | Streck, 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) |
| 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) |
| 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) |
| 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) |