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
21721–21744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2019
EarlyVue VS30
K190624 · DSJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 230d
Cleared Oct 25, 2019
Instruments for LINK MEGASYSTEM-C Family
K190181 · KRO
LinkBio Corp.
Orthopedic · 266d
Cleared Oct 25, 2019
IOB Warming Blankets
K190221 · DWJ
Iob Medical, Inc.
Cardiovascular · 262d
Cleared Oct 25, 2019
REDAPT Blade Augments
K190847 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 25, 2019
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
K191007 · IYN
Supersonic Imagine
Radiology · 192d
Cleared Oct 25, 2019
Maverick RNP Assay and Maverick Diagnostic System
K191085 · LKO
Genalyte, Inc.
Immunology · 184d
Cleared Oct 25, 2019
C-CAT Anaesthesia Catheter kit
K191470 · BSO
Cimpax Aps
Anesthesiology · 144d
Cleared Oct 25, 2019
FILTRAY 2G Disposable Water Filters
K191563 · NHV
Aqua-Tools
Gastroenterology & Urology · 134d
Cleared Oct 25, 2019
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807 · NXO
ALPCO
Immunology · 112d
Cleared Oct 25, 2019
F5 Corpus VS
K191874 · IPL
Permobil AB
Physical Medicine · 105d
Cleared Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
K192360 · DRF
Boston Scientific Corporation
Cardiovascular · 56d
Cleared Oct 25, 2019
Reusable Monopolar Active Cord
K192518 · GEI
Us Endoscopy
General & Plastic Surgery · 42d
Cleared Oct 25, 2019
gel-e Flex+ gel OTC
K192667 · QSY
Gel-E, Inc.
General & Plastic Surgery · 30d
Cleared Oct 25, 2019
MiniCap Extended Life PD Transfer Sets
K192705 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 28d
Cleared Oct 25, 2019
Cytal Wound Matrix 3-Layer
K192725 · KGN
Acell, Inc.
General & Plastic Surgery · 28d
Cleared Oct 25, 2019
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
K192787 · QDK
Dexcom, Inc.
Chemistry · 25d
Cleared Oct 24, 2019
Acapella Choice Blue Vibratory PEP Device
K181660 · BWF
Smiths Medical
Anesthesiology · 486d
Cleared Oct 24, 2019
Cronus HP PTA Balloon Catheter
K190037 · LIT
Nipro Medical Corporation
Cardiovascular · 289d
Cleared Oct 24, 2019
Tear Pool Dissolvable Punctum Plugs
K190210 · LZU
Alphamed, Inc.
Ophthalmic · 262d
Cleared Oct 24, 2019
MediExpand TL Expandable VBR System
K190349 · MQP
Cmf Medicon Surgical, Inc.
Orthopedic · 252d
Cleared Oct 24, 2019
ALTA Anterior Cervical Corpectomy System
K190426 · PLR
Astura Medical, LLC
Orthopedic · 244d
Cleared Oct 24, 2019
Zimmer Biomet Universal Navigation System
K190556 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 233d
Cleared Oct 24, 2019
Latex Surgeon’s Gloves Powder Free with protein content labeling claim of...
K190632 · KGO
Lenora Glove Pvt , Ltd.
General Hospital · 226d
Cleared Oct 24, 2019
Trident II Acetabular System
K191358 · LPH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 156d