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
23785–23808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2019
dpl SpotLite
K183118 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Feb 07, 2019
ArcTV Transvaginal Sling System
K183134 · OTN
Urocure, LLC
Gastroenterology & Urology · 86d
Cleared Feb 07, 2019
SonoSite SII Ultrasound System
K183235 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 79d
Cleared Feb 07, 2019
Parcus GFS BTB
K183331 · MBI
Parcus Medical, LLC
Orthopedic · 66d
Cleared Feb 07, 2019
Biomet Headless Compression and Twist-Off Screws
K190035 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Feb 06, 2019
CO2 Sampling Line
K181981 · CCK
Tylenol Medical Instruments Co., Ltd.
Anesthesiology · 196d
Cleared Feb 06, 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS...
K182102 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 187d
Cleared Feb 06, 2019
WavelinQ 4F EndoAVF System
K182796 · PQK
C.R. Bard, Inc.
Cardiovascular · 128d
Cleared Feb 06, 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...
K182885 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Feb 06, 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments,...
K183119 · OUR
Globus Medical, Inc.
Orthopedic · 89d
Cleared Feb 06, 2019
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
K183435 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 57d
Cleared Feb 06, 2019
Omnia Medical Rotary PLIF System
K183659 · MAX
Omnia Medical, LLC
Orthopedic · 41d
Cleared Feb 06, 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Feb 05, 2019
Absoanchor Microimplant
K181142 · OAT
Dentos, Inc.
Dental · 280d
Cleared Feb 05, 2019
PRECICE® BONE TRANSPORT™ System
K182170 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 179d
Cleared Feb 05, 2019
Spectra Optia Apheresis System
K183081 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 05, 2019
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with...
K183132 · LZC
O&M Halyard, Inc.
General Hospital · 84d
Cleared Feb 05, 2019
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
K183163 · MRD
Motiva USA, LLC
General & Plastic Surgery · 82d
Cleared Feb 05, 2019
JADE Mobile X-Ray
K183388 · IZL
DRGEM Corporation
Radiology · 61d
Cleared Feb 05, 2019
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
K183498 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 50d
Cleared Feb 04, 2019
d-Nav System
K181916 · NDC
Hygieia, Inc.
General Hospital · 202d
Cleared Feb 04, 2019
EIT Cellular Titanium Lumbar Cage - T/PLIF
K183447 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 54d
Cleared Feb 04, 2019
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
K183499 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 49d
Cleared Feb 04, 2019
Capture-CMV
K183571 · LJO
Immucor, Inc.
Microbiology · 45d