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
22321–22344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2019
Zurich Pressure Guidewire System Model 100
K190852 · DXO
Zurich Medical, Inc.
Cardiovascular · 134d
Cleared Aug 14, 2019
AutoStrut
K191241 · KTT
Orthospin
Orthopedic · 98d
Cleared Aug 14, 2019
NuVaisve® Reline® Cervical System
K191553 · NKG
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · LOL
Roche Diagnostics
Microbiology · 172d
Cleared Aug 13, 2019
PROSTEP™ TBI™ (Tailors Bunion Implant) System
K190970 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 123d
Cleared Aug 13, 2019
xPORT Lens Fragmentation System
K191024 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 117d
Cleared Aug 13, 2019
Modular Power Standing System
K191376 · IPL
Motion Concepts
Physical Medicine · 82d
Cleared Aug 13, 2019
Cartesion Prime
K191582 · KPS
Canon Medical Systems Corporation
Radiology · 60d
Cleared Aug 13, 2019
Instylla Microcatheter
K191731 · KRA
Instylla, Inc.
Cardiovascular · 46d
Cleared Aug 12, 2019
Critical Care Suite
K183182 · QFM
Ge Medical Systems, LLC
Radiology · 266d
Cleared Aug 12, 2019
Dr J Spinal and Epidural Needles
K183316 · BSP
Dr. Japan Co., Ltd.
Anesthesiology · 255d
Cleared Aug 12, 2019
EVOL® -SI Joint Fusion System
K190025 · OUR
Cutting Edge Spine, LLC
Orthopedic · 217d
Cleared Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
K190491 · NHA
Blue Sky Bio, LLC
Dental · 165d
Cleared Aug 12, 2019
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
K190870 · OVE
4Web, Inc.
Orthopedic · 131d
Cleared Aug 12, 2019
Arsenal Plating System
K191009 · HRS
Trilliant Surgical
Orthopedic · 118d
Cleared Aug 12, 2019
ATEC Lateral Interbody System
K191311 · MAX
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared Aug 12, 2019
Facilis™ Spinal System
K191494 · NKB
Baui Biotech Co., Ltd.
Orthopedic · 68d
Cleared Aug 09, 2019
Bone Screw, Bone Tack
K182881 · DZL
Osstem Implant Co., Ltd.
Dental · 298d
Cleared Aug 09, 2019
NxStage Cartridge Express with Speedswap
K183158 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 267d
Cleared Aug 09, 2019
ELAN 4 Tools
K183203 · HBE
Aesculap, Inc.
Neurology · 263d
Cleared Aug 09, 2019
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K183647 · GEX
Olympus Surgical Technologies America
General & Plastic Surgery · 226d
Cleared Aug 09, 2019
Morpheus-C
K190371 · MQV
Biogennix, LLC
Orthopedic · 175d
Cleared CT Aug 09, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...
K191114 · PQK
Avenu Medical
Cardiovascular · 105d
Cleared Aug 09, 2019
ARIETTA 750
K191233 · IYN
Hitachi Healthcare Americas
Radiology · 93d