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
22537–22560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2019
AcuSnare Polypectomy Snare - Duckbill
K191048 · FDI
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 18, 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit,...
K191060 · DXT
Acist Medical Systems, Inc.
General Hospital · 87d
Cleared Jul 18, 2019
MONTAGE-QS Settable, Resorbable Hemostatic Bone
K191140 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 79d
Cleared CT Jul 18, 2019
DreaMed Advisor Pro
K191370 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 57d
Cleared Jul 18, 2019
AOS ES Retrograde Femoral Nail
K191598 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 31d
Cleared Jul 18, 2019
Huvitz Imaging System
K191615 · NFJ
Huvitz Co., Ltd.
Ophthalmic · 30d
Cleared Jul 18, 2019
SPAR-K Instruments (for use with Gemini SL Total Knee System)
K191755 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 17d
Cleared Jul 17, 2019
The POD
K182820 · MQC
Advanced Facialdontics, LLC
Dental · 286d
Cleared Jul 17, 2019
Silent Nite sl
K183270 · LRK
Prismatik Dentalcraft, Inc.
Dental · 236d
Cleared Jul 17, 2019
Xtreme-Loop
K191053 · MBI
Xiros, Ltd.
Orthopedic · 89d
Cleared Jul 17, 2019
Powersculp laser lipolysis system
K191068 · PKT
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jul 17, 2019
Fungitell STAT
K191167 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 77d
Cleared Jul 17, 2019
Pegasus System
K191345 · HRX
A.M. Surgical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur...
K191578 · QFO
Siemens Healthcare Diagnostics, Inc.
Microbiology · 33d
Cleared Jul 17, 2019
ORTHOLOC™ SPS Shoulder Plating System
K191711 · HRS
Tornier, Inc.
Orthopedic · 21d
Cleared Jul 16, 2019
Biotex
K180992 · NBY
Purgo Biologics, Inc.
General & Plastic Surgery · 456d
Cleared Jul 16, 2019
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
K183051 · LJE
Cook Incorporated
Gastroenterology & Urology · 256d
Cleared Jul 16, 2019
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
K183572 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 207d
Cleared Jul 16, 2019
Microlife Digital Infrared Ear Thermometer
K183663 · FLL
Microlife Intellectual Property GmbH
General Hospital · 201d
Cleared Jul 16, 2019
Sage 2-in-1 Personal Lubricant and Moisturizer
K190150 · NUC
Fairhaven Health, LLC
Obstetrics & Gynecology · 167d
Cleared Jul 16, 2019
ALARA Neuro Access Kit
K190163 · PDQ
SurGenTec, LLC
Neurology · 166d
Cleared Jul 16, 2019
iBreastExam
K190575 · NKA
Ue Lifesciences, Inc.
Obstetrics & Gynecology · 132d
Cleared Jul 16, 2019
OptiFix AT Absorbable Fixation System with Articulating Technology – 30...
K191287 · GDW
Davol Inc., Subsidiary of C.R. Bard
General & Plastic Surgery · 64d
Cleared Jul 16, 2019
EMPOWR Partial Knee
K191325 · HSX
Encore Medical, L.P.
Orthopedic · 61d