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
30529–30552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 2016
W&H Implantmed SI-1015 incl. Accessories
K161957 · EBW
W&H Dentalwerk Burmoos GmbH
Dental · 128d
Cleared Nov 23, 2016
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice...
K162103 · MAX
Choicespine, LP
Orthopedic · 117d
Cleared Nov 23, 2016
Allura Xper R9
K162148 · OWB
Philips Medical Systems Nethrlands BV
Radiology · 114d
Cleared Nov 23, 2016
SILK Surgical Suture
K162396 · GAP
Teleflexmedical, Inc.
General & Plastic Surgery · 89d
Cleared Nov 23, 2016
Xpert MRSA NxG
K162444 · NQX
Cepheid
Microbiology · 84d
Cleared Nov 23, 2016
AMICUS Separator System, AMICUS Separator System
K162462 · GKT
Fresenius Kabi USA,Llc
Hematology · 82d
Cleared Nov 23, 2016
Biomet Microfixation SternaLock 360 Sternal Closure System
K163007 · HRS
Biomet Microfixation
Orthopedic · 26d
Cleared Nov 22, 2016
Disposable High Pressure Injector Syringe
K152906 · DXT
Wuxi Yushou Medical Appliances Co., Ltd.
General Hospital · 418d
Cleared Nov 22, 2016
Fingertip Pulse Oximeter A310
K153021 · DQA
Amemo, Inc.
Anesthesiology · 404d
Cleared Nov 22, 2016
Disposal Lens Cleaning Sheath
K153773 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 327d
Cleared Nov 22, 2016
MRWire Guide Wire
K160594 · DQX
Nano4imaging GmbH
Cardiovascular · 266d
Cleared Nov 22, 2016
DW-1C
K160761 · NEW
Dongwon Medical Co., Ltd.
General & Plastic Surgery · 246d
Cleared Nov 22, 2016
U&U Enteral Syringe
K160855 · PNR
U&U Medical Technology Co, Ltd.
Gastroenterology & Urology · 239d
Cleared Nov 22, 2016
CXI Support Catheter
K160884 · KRA
Cook Incorporated
Cardiovascular · 236d
Cleared Nov 22, 2016
ConvertX Nephroureteral Stent System
K161277 · FAD
Brightwater Medical
Gastroenterology & Urology · 200d
Cleared Nov 22, 2016
Compass Cast and MAP
K161408 · DRS
Centurion Medical Products Corporation
Cardiovascular · 186d
Cleared Nov 22, 2016
Temporary Snap Abutment
K161435 · NHA
Nobel Biocare AB
Dental · 182d
Cleared Nov 22, 2016
Arm automatic blood pressure monitor
K161708 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 154d
Cleared Nov 22, 2016
LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5
K161747 · HRS
Aap Implantate AG
Orthopedic · 151d
Cleared Nov 22, 2016
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 148d
Cleared Nov 22, 2016
ToeTac™ 10° Hammertoe Fixation System
K161778 · HWC
Restore Surgical, LLC Dba Instratek
Orthopedic · 146d
Cleared Nov 22, 2016
Pacel Flow Directed Pacing Catheter
K161873 · LDF
St Jude Medical
Cardiovascular · 138d
Cleared Nov 22, 2016
Leva® Anterior Interbody System
K161993 · OVD
Spine Wave, Inc.
Orthopedic · 126d
Cleared Nov 22, 2016
NobelProcera HT ML FCZ Bridge
K162043 · ELL
Nobel Biocare AB
Dental · 120d