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
17521–17544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2021
Stockert S5 System
K210130 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 76d
Cleared Apr 05, 2021
ADAS 3D
K210850 · LLZ
Adas3D Medical S.L.
Radiology · 14d
Cleared Apr 02, 2021
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe...
K201171 · GEX
Leoni Fiber Optics, Inc.
General & Plastic Surgery · 336d
Cleared Apr 02, 2021
Apex Knee System
K201611 · JWH
Omnilife Science
Orthopedic · 291d
Cleared Apr 02, 2021
Porcine Mineral Collagen Composite
K202183 · NPM
Collagen Matrix, Inc.
Dental · 241d
Cleared Apr 02, 2021
SkinPen Precision System
K202243 · QAI
Crown Aesthetics
General & Plastic Surgery · 235d
Cleared Apr 02, 2021
Eclipse II with Smart Noise Cancellation
K202441 · MQB
Carestream Health, Inc.
Radiology · 219d
Cleared Apr 02, 2021
Medline Orbis Surgical Gown
K202447 · FYA
Medline Industries, Inc.
General Hospital · 219d
Cleared Apr 02, 2021
CreoDent Solidex Customized Abutment
K202909 · NHA
Creodent Prosthetics, Ltd.
Dental · 185d
Cleared Apr 02, 2021
DV. Target
K202928 · QKB
Deepvoxel, Inc.
Radiology · 185d
Cleared Apr 02, 2021
Global Shoulder and Delta CTA systems
K203230 · KWS
Depuy Lnc.
Orthopedic · 151d
Cleared Apr 02, 2021
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
K203310 · JOW
Jiangsu Synecoun Medical Technology...
Cardiovascular · 143d
Cleared Apr 02, 2021
KMTI Hip Replacement System
K203472 · OQG
Kyocera Medical Technologies, Inc.
Orthopedic · 128d
Cleared Apr 02, 2021
Pristine Long-Term Hemodialysis Catheter
K203767 · MSD
C B Bard, Inc.
Gastroenterology & Urology · 100d
Cleared Apr 02, 2021
DeGen Navigated Instrumentation
K203816 · OLO
Degen Medical
Orthopedic · 94d
Cleared Apr 02, 2021
Surgical Face Mask
K210023 · FXX
Guangdong Winsun Personal Care...
General Hospital · 88d
Cleared Apr 02, 2021
ClearPath Disposable Introducer
K210251 · GWG
Clearmind Biomedical
Neurology · 63d
Cleared Apr 02, 2021
Polaris Spinal System
K210275 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 60d
Cleared Apr 02, 2021
DigitalDiagnost
K210692 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 25d
Cleared Apr 02, 2021
Extended HA Half Pins
K210784 · JDW
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Apr 01, 2021
Idys LLIF 3DTi
K202032 · OVD
Clariance, Sas
Orthopedic · 253d
Cleared Apr 01, 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact...
K202129 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 244d
Cleared Apr 01, 2021
B-Capta
K202154 · DRY
Livanova Deutschland, GmbH
Cardiovascular · 241d
Cleared Apr 01, 2021
AMG PMP Pediatric
K202206 · DTZ
Eurosets S.R.L
Cardiovascular · 239d