GEIK253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
Medtronic Sofamor Danek USA, Inc. | United States
2026-06-05
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OLOK260571SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
Life Spine, Inc. | Robotic Navigation | Spine Surgery | United States
2026-06-02
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GEIK253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
F Care Systems USA, LLC | United States
2026-06-02
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GEIK253803MILAN System
Lumenis Be, Ltd. | Israel
2026-06-02
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GEIK261202ENTire IRE System
Entire Medical , Ltd. | RF Ablation | Surgery | Israel
2026-05-29
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OLOK261060Navigated LLIF Impactable Tracker
Tyber Medical, LLC | Stereotactic Surgery | Spine Surgery | United States
2026-05-29
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GEXK260138LUNE PureHygiene
Enamel Pure | United States
2026-05-29
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OLOK254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
Medos International SARL | Software Navigation | Spine Surgery | Switzerland
2026-05-26
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Browse by category
FDA product codes with indexed clearances and companies
GEX
Laser & light therapy
Powered laser and light-based surgical instruments for general surgery, dermatology, and plastic surgery (21 CFR 878.4810).
- Clearances
- 668
- Companies
- 262
Diode · Nd:YAG
OHT
OTC light-based hair removal
Over-the-counter light-based devices that use thermal energy for hair removal (21 CFR 878.4810, product code OHT).
- Clearances
- 145
- Companies
- 78
IPL · Diode laser
GEI
Energy-based Device
Devices that utilize energy for therapeutic or surgical purposes, typically referenced under CFR 21 878.4810.
- Clearances
- 74
- Companies
- 58
RF Ablation · RF Generator
OLO
Robotic Surgical Navigation System
Devices that assist in surgical navigation using robotic technology for improved precision and outcomes.
- Clearances
- 196
- Companies
- 84
Robotic Navigation · Image Guided Surgery
Companies
Ranked by total indexed 510(k) clearances · showing 1–10 of 464
Quanta System Spa
38 clearances | Italy | Latest 2025-06-06
Wontech Co., Ltd.
23 clearances | Korea, Republic of | Latest 2025-12-19
Shenzhen Ulike Smart Electronics Co., Ltd.
18 clearances | China | Latest 2026-05-21
Lumenis, Inc.
15 clearances | United States | Latest 2022-06-21
El.En Electronic Engineering Spa
14 clearances | Italy | Latest 2023-01-04
Asclepion Laser Technologies GmbH
13 clearances | Germany | Latest 2026-04-29
Fotona D.O.O.
13 clearances | Slovenia | Latest 2024-08-23
Alma Lasers, Inc.
12 clearances | United States | Latest 2025-09-24
Cyden Limited
11 clearances | United Kingdom | Latest 2024-11-27
Laseroptek Co., Ltd.
11 clearances | Korea, Republic of | Latest 2025-02-07
Latest clearances
Recently cleared devices across Benchmed categories
How Benchmed works
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Look up a K number, find a company, or pick a device category, or explore companies and predicate chains.
- 2
Review clearance details
See device metadata, Summary excerpts, and predicate relationships parsed from FDA public records.
- 3
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Data is sourced online and refined with AI — always confirm accuracy against official FDA filings.
