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
27937–27960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2017
FiberTak DX
K172612 · MBI
Arthex, Inc.
Orthopedic · 28d
Cleared Sep 28, 2017
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU -...
K172659 · GAM
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 23d
Cleared Sep 27, 2017
Cetus system, Cetus probe
K170183 · HQE
A.R.C Laser GmbH
Ophthalmic · 247d
Cleared Sep 27, 2017
Spider Frame External Fixation System
K170482 · KTT
Tasarimmed Tibbi Mamuller Sanayi VE...
Orthopedic · 223d
Cleared Sep 27, 2017
CRYOFOS
K170810 · GEH
Cryofos Medical GmbH
General & Plastic Surgery · 194d
Cleared Sep 27, 2017
OIC External Fixation System
K171211 · KTT
Orthopaedic Implant Company
Orthopedic · 155d
Cleared Sep 27, 2017
QiF Blood and Fluid Warmer
K171215 · LGZ
Quality IN Flow , Ltd.
General Hospital · 155d
Cleared Sep 27, 2017
Scopis Extended Instrument Set EM
K171661 · PGW
Scopis GmbH
Ear, Nose, Throat · 114d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936 · DSH
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Sep 27, 2017
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 91d
Cleared Sep 27, 2017
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
K172109 · JWY
Liofilchem S. R. L.
Microbiology · 76d
Cleared Sep 27, 2017
Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
K172275 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 61d
Cleared Sep 26, 2017
Vesco Medical Nasoenteric Feeding Tubes
K170162 · PIF
Vesco Medical, LLC
Gastroenterology & Urology · 251d
Cleared Sep 26, 2017
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine...
K170816 · LLZ
Brainlab AG
Radiology · 190d
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit,...
K171963 · OCC
Hologic, Inc.
Microbiology · 88d
Cleared Sep 26, 2017
SculpSure
K171992 · PKT
Cynosure, Inc.
General & Plastic Surgery · 85d
Cleared Sep 26, 2017
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
K172015 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 85d
Cleared Sep 26, 2017
ROMEO® 2 Posterior Osteosynthesis System
K172101 · NKB
Spineart
Orthopedic · 76d
Cleared Sep 26, 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 29d
Cleared Sep 25, 2017
ISEN-Goggles with Data Viewer
K163270 · GWN
Isent Tech & Trading Company, Ltd.
Neurology · 308d
Cleared Sep 25, 2017
Ecofit® Hip System
K163577 · LZO
Implantcast GmbH
Orthopedic · 279d
Cleared Sep 25, 2017
INDEPENDENCE® Spacers
K170157 · OVD
Globus Medical, Inc.
Orthopedic · 250d
Cleared Sep 25, 2017
Urbanek Device
K170985 · MQC
Tmj Services, LLC
Dental · 175d