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
20737–20760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2020
Elecsys Anti-TSHR
K193313 · JZO
Roche Diagnostics
Immunology · 90d
Cleared Feb 27, 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
K200206 · QJP
Stryker Neurovascular
Neurology · 30d
Cleared Feb 27, 2020
Fusion Quattro Extraction Balloon
K200247 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 26, 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · JDR
Synthes USA Products, LLC
Orthopedic · 268d
Cleared Feb 26, 2020
VSP System
K192192 · DZJ
3D Systems
Dental · 197d
Cleared Feb 26, 2020
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical...
K193506 · MQP
Nu Vasive, Incorporated
Orthopedic · 70d
Cleared Feb 26, 2020
Luna Dental Implant System- Healing Abutment
K200189 · NHA
Shinhung Mst Co., Ltd.
Dental · 30d
Cleared Feb 26, 2020
ARK Fentanyl II Assay
K200197 · DJG
ARK Diagnostics, Inc.
Toxicology · 30d
Cleared Feb 25, 2020
Allcem Veneer APS
K191389 · EBF
Dentscare Ltda
Dental · 277d
Cleared Feb 25, 2020
Heater-Cooler System 3T
K191402 · DWC
Livanova Deutschland, GmbH
Cardiovascular · 277d
Cleared Feb 25, 2020
SonicEye Dual-Array Ultrasound System
K192253 · IYO
Sonivate Medical, Inc.
Radiology · 189d
Cleared Feb 25, 2020
PneumoLiner
K192898 · PMU
Advanced Surgical Concepts
Obstetrics & Gynecology · 137d
Cleared Feb 25, 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 78d
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016 · JAK
Shanghai United Imaging Healthcare...
Radiology · 53d
Cleared Feb 25, 2020
Ez3D-i /E3
K200178 · LLZ
Ewoosoft Co., Ltd.
Radiology · 32d
Cleared Feb 25, 2020
Surgical laser fibers
K200234 · GEX
Quanta System Spa
General & Plastic Surgery · 26d
Cleared Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236 · PMT
Ortho-Clinical Diagnostics
Microbiology · 26d
Cleared Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry...
K191474 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 265d
Cleared Feb 24, 2020
Pylant Monitor
K191858 · BSK
Kal-Med, LLC
Anesthesiology · 228d
Cleared Feb 24, 2020
Aquadex FlexFlow System 2.0
K192756 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 147d
Cleared Feb 24, 2020
DELTA XTEND(TM) Reverse Shoulder System
K192855 · PHX
Depuy(Ireland)
Orthopedic · 143d
Cleared Feb 24, 2020
Alliance Augmented Glenoid
K193180 · KWS
Zimmer, Inc.
Orthopedic · 98d
Cleared Feb 24, 2020
NEXXT MATRIXX System
K193412 · PLR
Nexxt Spine, LLC
Orthopedic · 77d
Cleared Feb 24, 2020
Titanium Interference Screws
K193451 · HWC
Biomet, Inc.
Orthopedic · 73d