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
22513–22536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2019
Surdial DX Hemodialysis System
K182940 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 269d
Cleared Jul 19, 2019
SpaceOAR Vue Hydrogel
K182971 · OVB
Augmenix, Inc.
Radiology · 266d
Cleared Jul 19, 2019
AeroDVx System
K183349 · JOW
Sun Scientific, Inc.
Cardiovascular · 228d
Cleared Jul 19, 2019
Anspach Helix Dissection Tools
K183545 · HBE
The Anspach Effort, Inc.
Neurology · 211d
Cleared Jul 19, 2019
Tech Dots - Adhesive and conductive gel
K190050 · GYB
Spes Medica Srl
Neurology · 190d
Cleared Jul 19, 2019
STERIZONE(R) VP4 Sterilizer
K190260 · PJJ
Tso3, Inc.
General Hospital · 161d
Cleared Jul 19, 2019
NvisionVLE Low-profile Optical Probe
K191117 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 84d
Cleared Jul 19, 2019
syngo.via MI Workflows VB40A, Scenium
K191309 · LLZ
Siemens Medical Soultions USA, Inc.
Radiology · 66d
Cleared Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191365 · JGS
Nova Biomedical Corporation
Chemistry · 58d
Cleared Jul 19, 2019
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
K191467 · IYN
Canon Medical Systems Corporation
Radiology · 46d
Cleared Jul 19, 2019
Infyna Chic
K191633 · GBM
Hollister Incorporated
Gastroenterology & Urology · 30d
Cleared Jul 19, 2019
Mariner MIS Pedicle Screw System
K191648 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Jul 19, 2019
EUROPA Pedicle Screw System
K191757 · NKB
MiRus, LLC
Orthopedic · 18d
Cleared Jul 18, 2019
Trilogy Evo
K181166 · CBK
Respironics, Inc.
Anesthesiology · 442d
Cleared Jul 18, 2019
Trilogy Evo Universal
K181170 · CBK
Respironics, Inc.
Anesthesiology · 442d
Cleared Jul 18, 2019
BionicGym Powered Muscle Stimulator
K182794 · NGX
Medical Currents, Ltd.
Physical Medicine · 290d
Cleared Jul 18, 2019
Ziacom Dental Implant Systems
K182908 · DZE
Ziacom Medical, S.L.
Dental · 274d
Cleared Jul 18, 2019
Qraypen
K183121 · EIA
AIOBIO Co., Ltd.
Dental · 251d
Cleared Jul 18, 2019
Latitud Hip Replacement System
K183532 · LZO
Meril Healthcare Pvt. , Ltd.
Orthopedic · 211d
Cleared Jul 18, 2019
Silverlon Wound Contact, Burn Contact Dressings
K190343 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 154d
Cleared Jul 18, 2019
Immucise
K190427 · FMF
Terumo Corporation
General Hospital · 146d
Cleared Jul 18, 2019
Peralta Stone Removal Catheter
K190492 · FFL
Calcula Technologies, Inc.
Gastroenterology & Urology · 140d
Cleared Jul 18, 2019
FAVO S-TLIF
K190680 · MAX
Silony Medical GmbH
Orthopedic · 122d
Cleared Jul 18, 2019
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY...
K190895 · NKG
Medos International SARL
Orthopedic · 104d