510(k) Clearances — Page 190
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230551 — Visual-ICE Cryoablation System | Boston Scientific Corporation Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223633 — Rubicon Control Support Catheter (H749394323506A1) | Boston Scientific Corporation Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232052 — Ceribell Instant EEG Headband | Ceribell, Inc. Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231857 — Arthrex TightRope II | Arthrex, Inc. Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232008 — Disposable Medical Examination Nitrile Gloves | Raxwell Industrial, LLC Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223924 — LW Implant System | Ossvis Co., Ltd. Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220828 — SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231488 — Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | Steris Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231500 — Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231490 — Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223713 — Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231501 — PRO-LITE Sterilization Tray | STERIS Corporation Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231098 — LineSider® Spinal System | Integrity Implants, Inc. Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223476 — V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230376 — Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230733 — Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG Sat Aug 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230126 — Dentis s-Clean Regular Abutment | Dentis Co., Ltd. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232005 — HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | Smith & Nephew, Inc. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231370 — Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co. , Ltd. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220031 — Alinity h-series System | Abbott Laboratories Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231333 — STRETTO Cable System | Globus Medical, Inc. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223673 — Surgeon Controlled Arm | Levita Magnetics International Corp Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222635 — Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230672 — Annabella Breast Pump | Annabella , Ltd. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223507 — CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223787 — ECGenius System | Cath Vision Aps Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223431 — Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231404 — T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | Healthium Medtech Limited Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221138 — Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232010 — iTEMPSHIELD | Aion Biosystems, Inc. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231400 — Bladeless Trocar Artemis Lap Cannula | T.A.G. Medical Products Corporation, Ltd. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232006 — LEGACY® IPC | Ig Technology, Ltd. Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231458 — Extremity Staple | Restor3D Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231654 — NorthStar OCT System | Seaspine, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232132 — LifeSPARC System | Cardiacassist, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231831 — TiLink-L Joint Fusion System | Surgentec Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223542 — TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223122 — MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230380 — Surgical Face Masks, Model: EFMDS-L50Pn BLU | Iris USA Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232058 — YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223133 — VisiRad XR | Imidex, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230003 — Viz HCM | Viz. Ai, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | Atmos Medizintechnik GmbH & Co. KG Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231548 — Medical Diode Laser, Model S1Pro | Wuhan Pioon Technology Co., Ltd. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221894 — Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230419 — Sequel Tampon with Plastic Applicator | Tampro, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223551 — Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230613 — SKEEPER | Smartsound Corporation Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |