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
361–384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2026
Automatic Core Biopsy Instrument
K260517 · KNW
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 192d
Cleared Aug 28, 2026
Carescape Canvas 1000
K260343 · MHX
GE Healthcare Finland Oy
Cardiovascular · 207d
Cleared Aug 28, 2026
Fule Vertebroplasty Balloon Catheter
K260203 · HRX
Beijing Fule Science & Technology...
Orthopedic · 217d
Cleared Aug 28, 2026
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190)
K260047 · PGX
Roche Molecular Systems, Inc.
Microbiology · 233d
Cleared Aug 28, 2026
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190)
K260045 · OZN
Roche Molecular Systems, Inc.
Microbiology · 233d
Cleared Aug 28, 2026
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK
K254261 · MQL
CELL STORE (BEIJING) BIOTECHNOLOGY...
Obstetrics & Gynecology · 241d
Cleared Aug 28, 2026
X-Guide Surgical Navigation System
K253954 · QRY
X-Nav Technologies, LLC
Dental · 261d
Cleared Aug 28, 2026
Mpact 3D Metal Foam
K253630 · LPH
Medacta International S.A.
Orthopedic · 282d
Cleared Aug 27, 2026
GenesisX RMN
K262744 · DXX
Stereotaxis, Inc.
Cardiovascular · 24d
Cleared Aug 27, 2026
Iconix Knotless T
K262677 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Aug 27, 2026
Dexus Prosthetic System (MSL2, MSR2)
K262654 · GXY
Zhejiang Qiangnao Technology Co.,Ltd
Neurology · 28d
Cleared Aug 27, 2026
Optiflow Oxygen Kit (AA484J)
K262268 · BTT
Fisher and Paykel Healthcare Limited
Anesthesiology · 52d
Cleared Aug 27, 2026
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
K262104 · LRK
Ram.Shaw Pte. , Ltd.
Dental · 65d
Cleared Aug 27, 2026
1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
K261821 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 87d
Cleared Aug 27, 2026
Glidewell™ Denture Base Resin
K261802 · EBI
Prismatik Dentalcraft, Inc.
Dental · 87d
Cleared Aug 27, 2026
EasyCare Tx 2
K261360 · MOD
ResMed Corp
Anesthesiology · 125d
Cleared Aug 27, 2026
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and...
K260870 · MLY
Gebauer Company
Physical Medicine · 163d
Cleared Aug 27, 2026
Disposable Distal Attachment D-201-13404
K260856 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 164d
Cleared Aug 27, 2026
Gastrointestinal Videoscope Olympus GIF-2T1500
K260824 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 167d
Cleared Aug 27, 2026
35 Helix Guidewire
K260751 · MOF
Piraeus Medical, Inc.
Neurology · 174d
Cleared Aug 27, 2026
Accelagen Plus Surgical Matrix, 1cc (CG-01AP)
K260711 · KGN
Berkeley Advanced Biomaterials
General & Plastic Surgery · 175d
Cleared Aug 27, 2026
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K260545 · NBW
Ascensia Diabetes Care
Chemistry · 190d
Cleared Aug 27, 2026
GC85A
K260481 · KPR
Samsung Electronics Co., Ltd.
Radiology · 195d
Cleared Aug 27, 2026
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
K260401 · PSV
Olympus Medical Systems Corporation
Ear, Nose, Throat · 202d