510(k) Clearances — Page 116
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K210933 — YSI 2900C Biochemistry Analyzer | Ysi, Inc. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241939 — EasyCare Tx 2 | Resmed Corp Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241536 — trophon Wireless Ultrasound Probe Holder | Nanosonics Limited Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241933 — HIGHERDOSE Red and Infrared Light Mask (MK66-L) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242557 — ClotTriever XL Catheter (41-102) | Inari Medical, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240220 — Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241447 — iCare ST500 (TA04) | Icare Finland OY Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241480 — JBS-LVO | JLK, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240017 — ShortCut | Pi-Cardia, Ltd. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 | Hyundae Meditech Co., Ltd. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241916 — TearRepair Liquid Skin Protectant | Optmed, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233446 — AMC Health CareConsole | Amc Health Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240745 — ID Free Personal Lubricant | Westridge Laboratories, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240993 — encevis (2.1) | Ait Austrian Institute of Technology GmbH Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242582 — Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240369 — CAC (gated) Algorithm | BunkerHill Health Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242125 — Elvie Stride 2 | Chiaro Technology, Ltd. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241909 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241513 — Sourcerer | Brain Electrophysiology Laboratory Company, LLC Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242206 — ACTIVO | Daeju Meditech Engineering Co., Ltd. Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241147 — Any-Com | Mediclus Co., Ltd. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | Circa Scientific, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242632 — Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241341 — cryo-GO Vitrification Device | Fujifilm Irvine Scientific Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241815 — Protean Fragment Plating System | Skeletal Dynamics, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241895 — Cannulated PsiFGuard | Spineguard Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240854 — Accelerate Arc System | Accelerate Diagnostics, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234149 — MOLLI 2 System | Molli Surgical, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241651 — Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241101 — BioButton System | Biointellisense, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241027 — Permatage Settable Bone Putty | Orthocon, Inc. Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241216 — myAir | Resmed Corp Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242075 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240042 — MOLLI 2 System | Molli Surgical, Inc. Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240041 — IVD CAPSULE PSP; abioSCOPE | Abionic SA Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242204 — Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) | Dongguan Quanding Medical Supplies Co., Ltd. Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242299 — NovaBone Putty - Synthetic Bioactive Bone Graft | Novabone Products, LLC Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242273 — Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241535 — Vybe RF II | ShenB Co., Ltd. Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241860 — Diode Laser Hair Removal System | Beijing Winkonlaser Technology Limited Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | Li Medical Corporation , Ltd. Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240776 — Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234134 — AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | Resmed Pty Ltd (Registration Number: 3004604967) Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242292 — uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242070 — Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240236 — Happy Ring Health Monitoring System | Happy Health, Inc. Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |