510(k) Clearances — Page 156
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233914 — XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233476 — Z1 Hip System | Orchard Medical Development Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230839 — Concentriq Dx | Proscia, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233184 — T2Bacteria® Panel | T2biosystems, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233350 — SINC Support Catheter | Reflow Medical, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233480 — Access SHBG | Beckman Coulter, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240086 — Ion 3D | SurGenTec, LLC Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240064 — Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240075 — FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Eco Medi Glove Sdn. Bhd. Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232171 — Purema® H Hemoconcentrator (EtO Sterilized) | Tecnoideal America Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231956 — F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233416 — Cryojet Plus (SHE-ACP001-1) | Beijing Sano Laser S&T Development Co.,Ltd Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233897 — 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | Shenzhen Beacon Display Technology Co., Ltd. Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233115 — Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233960 — INNOVERSE Spinal System | Innosys Co., Ltd. Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233593 — MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230041 — Sleep Apnea Feature | Samsung Electronics Co., Ltd. Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233221 — Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Metro Optics of Austin, Inc. Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233600 — Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232363 — Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232694 — Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234075 — Flow-Nail | Flow-Fx, LLC Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234013 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE | Bone Solutions, Inc. Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co, Ltd. Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233895 — EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); | Edwards Lifesciences Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232379 — PREVENT Kit | Clear Choice Therapeutics Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240099 — Ziehm Vision RFD | Ziehm Imaging GmbH Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra Lifesciences Production Corporation Sun Feb 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232210 — X-trodes System M | X-Trodes Sun Feb 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233143 — PiXel8-Reveal | Rohrer Aesthetics Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231534 — 5008X Hemodialysis System | Fresenius Medical Care Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240030 — Indigo® Aspiration System - Lightning® Flash | Penumbra, Inc. Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230548 — Myoaligner Appliance | Myohealth Technologies, LLC Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231325 — Corplex P / Theracor P / Allacor P | Stimlabs, LLC Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233531 — OIC FLEX-FIX System | Orthopaedic Implant Company Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233756 — Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) | Rhein Laser Technologies Co., Ltd. Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231373 — BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231625 — VitalDetect | Wellvii, Inc. Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233855 — AllPEP | Enchant Tek Co. , Ltd. Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233472 — CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230657 — BTL-99-OC | BTL Industries, Inc. Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232165 — Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Berpu Medical Technology Co., Ltd. Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233183 — Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240018 — WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232949 — Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232339 — Augmented Reality Application | Sira Medical, Inc. Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233804 — Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232007 — CAAS MR Solutions | Pie Medical Imaging BV Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |