FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
721–744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2026
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
K261775
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 53d
Cleared Jul 21, 2026
Medical Thulium Fiber Laser Systems (UroFiber 150Q)
K261738 · GEX
Rhein Laser Technologies Co., Ltd.
General & Plastic Surgery · 55d
Cleared Jul 21, 2026
One-Fil LC
K261728 · EJK
Mediclus Co., Ltd.
Dental · 56d
Cleared Jul 21, 2026
Versalock Proximal Tibial Plating System
K261406 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 83d
Cleared Jul 21, 2026
NOVEOS Specific IgE (sIgE)
K260591 · DHB
Hycor Biomedical
Immunology · 148d
Cleared Jul 21, 2026
ResolutionMD
K260500 · LLZ
ResolutionMD, Inc.
Radiology · 158d
Cleared Jul 21, 2026
Raney Clips Kit
K253814 · HBO
Beijing Honghugaoxiang Science and...
Neurology · 235d
Cleared Jul 21, 2026
CardIQ Suite
K253770 · JAK
GE Medical Systems SCS
Radiology · 237d
Cleared Jul 20, 2026
Thunderbolt System
K261632 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 63d
Cleared Jul 20, 2026
ENDOSCOPE HOLDER (182214)
K261573 · QZB
Aktormed GmbH
General & Plastic Surgery · 69d
Cleared Jul 20, 2026
Hi-D Imaging 4TAVR
K261535 · QIH
Hi-D Imaging AG
Radiology · 73d
Cleared Jul 20, 2026
Sleep Apnea Feature (v2.0)
K261011 · QZW
Samsung Electronics Co., Ltd.
Anesthesiology · 116d
Cleared Jul 20, 2026
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C,...
K260516 · FGB
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 153d
Cleared Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K254285 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 201d
Cleared Jul 20, 2026
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating...
K254231 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 203d
Cleared Jul 17, 2026
Tritanium® C Anterior Cervical Cage
K262061 · ODP
Stryker Spine
Orthopedic · 29d
Cleared Jul 17, 2026
AssureTech Quick Cup Tests
K261984 · NFT
Assure Tech., LLC
Toxicology · 35d
Cleared Jul 17, 2026
Diode laser hair removal machine (QDTM-04)
K261693 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jul 17, 2026
CHZL Red Light Therapy Hair Growth Cap...
K261675 · OAP
Shenzhen Chuanghong Zhilian...
General & Plastic Surgery · 57d
Cleared Jul 17, 2026
LoFric Origo Pro Coudé
K261658 · EZD
Wellspect AB
Gastroenterology & Urology · 59d
Cleared Jul 17, 2026
LED LCD Monitor (OEV-271H)
K261614 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 63d
Cleared Jul 17, 2026
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
K261475 · PMN
Biofire Defense, LLC
Microbiology · 73d
Cleared Jul 17, 2026
Dental Zirconia Blank & Coloring Liquid
K261046 · EIH
Hunan Qinghao Puzhong Technology Co.,...
Dental · 108d
Cleared Jul 17, 2026
ZEISS CLINIC 360
K260694 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 136d