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
28897–28920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170354 · NHA
Institut Straumann AG
Dental · 121d
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170356 · NHA
Institut Straumann AG
Dental · 121d
Cleared Jun 07, 2017
Vantage Titan 1.5T, MRT-1510, M-Power GX
K170412 · LNH
Toshibamedical Systems Corporation
Radiology · 117d
Cleared Jun 07, 2017
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 98d
Cleared Jun 07, 2017
E. HISTOLYTICA QUIK CHEK
K170728 · KHW
Techlab, Inc.
Microbiology · 90d
Cleared Jun 07, 2017
HySil Impression Materials
K170736 · ELW
Osstem Implant Co., Ltd.
Dental · 89d
Cleared Jun 07, 2017
MRIdian Linac System with 138-leaf Collimator
K170751 · IYE
Viewray, Incorporated
Radiology · 86d
Cleared Jun 07, 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
K170772 · JWY
Liofilchem S. R. L.
Microbiology · 85d
Cleared Jun 07, 2017
Cochlear Baha SoundArc
K171088 · LXB
Cochlear Americas
Ear, Nose, Throat · 56d
Cleared Jun 07, 2017
Venture 038 catheter
K171335 · DQY
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2017
CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
K171353 · IZL
Minxray, Inc.
Radiology · 29d
Cleared Jun 07, 2017
SurgiMend PRS Meshed, Revize-X
K171357 · OXH
Integra Lifesciences Corporation...
General & Plastic Surgery · 29d
Cleared Jun 06, 2017
MOVES SLC
K161420 · BTL
Thornhill Research, Inc.
Anesthesiology · 379d
Cleared Jun 06, 2017
QT Ultrasound Breast Scanner-1
K162372 · IYO
Qt Ultrasound, LLC
Radiology · 286d
Cleared Jun 06, 2017
Digital Thermometer
K163603 · FLL
Guangzhou Jinxinbao Electronic Co., Ltd.
General Hospital · 167d
Cleared Jun 06, 2017
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
K170044 · NHA
Prismatik Dentalcraft, Inc.
Dental · 152d
Cleared Jun 06, 2017
EK12 Algorithm
K170155 · MHX
Ge Medical Systems Information...
Cardiovascular · 139d
Cleared Jun 06, 2017
SonoBook Series Diagnostic Ultrasound System
K170374 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 119d
Cleared Jun 06, 2017
Altomed Malhotra Platinum Segments
K170591 · MML
Altomed Limited
Ophthalmic · 98d
Cleared Jun 06, 2017
Flower Bone Screw Set
K170687 · HWC
Flower Orthopedics Corporation
Orthopedic · 91d
Cleared CT Jun 06, 2017
CURVE Laser System
K170709 · OLI
Yolo Medical, Inc.
General & Plastic Surgery · 90d
Cleared Jun 06, 2017
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection,...
K171347 · PIF
Xeridiem Medical Devices
Gastroenterology & Urology · 29d
Cleared Jun 06, 2017
Magnetic Surgical System
K171429 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 22d
Cleared Jun 05, 2017
APVolution System
K163228 · EIH
Aesthetic-Press, LLC
Dental · 200d