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
23569–23592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2019
Brainsway Deep TMS System
K183303 · QCI
Brainsway , Ltd.
Neurology · 101d
Cleared Mar 08, 2019
NewTom 5G XL
K183448 · JAK
Cefla S.C.
Radiology · 86d
Cleared Mar 08, 2019
EchoSure Diagnostic Ultrasound System
K190039 · IYO
Sonavex, Inc.
Radiology · 59d
Cleared Mar 08, 2019
Nexus DR Digital X-ray Imaging System
K190146 · MQB
Varex Imaging Corporation
Radiology · 38d
Cleared Mar 08, 2019
RadiForce MX216
K190153 · PGY
Eizo Corporation
Radiology · 37d
Cleared Mar 08, 2019
CORUS Spinal System
K190201 · HRX
Providence Medical Technology, Inc.
General & Plastic Surgery · 32d
Cleared Mar 08, 2019
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A...
K190206 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 32d
Cleared Mar 08, 2019
Medline Burn and Wound Dressing (OTC)
K190224 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 31d
Cleared Mar 08, 2019
Rulo Radiofrequency Lesion Probe
K190256 · GXI
Epimed International, Inc.
Neurology · 29d
Cleared Mar 08, 2019
Provident II Hip Stem
K190276 · LPH
Stelkast, Inc.
Orthopedic · 28d
Cleared Mar 07, 2019
Spectrum Spine Expandable Cages (SSEC)
K173518 · MAX
Spectrum Spine, LLC
Orthopedic · 478d
Cleared Mar 07, 2019
DARI Health
K180880 · LXJ
Scientific Analytics, Inc.
Physical Medicine · 338d
Cleared Mar 07, 2019
Philips wearable biosensor-G5 Solution
K181165 · DRT
Connected Sensing- A Division of...
Cardiovascular · 309d
Cleared Mar 07, 2019
Cervella
K182311 · QJQ
Innovative Neurological Devices, LLC
Neurology · 195d
Cleared Mar 07, 2019
RhythmAnalytics
K182344 · DQK
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 191d
Cleared Mar 07, 2019
Electric Breast Pump
K182413 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 184d
Cleared Mar 07, 2019
Introcan Safety 3 Closed IV Catheter
K182870 · FOZ
B.Braun Medical, Inc.
General Hospital · 146d
Cleared Mar 07, 2019
VitalConnect Platform, VitalPatch Biosensor
K183078 · DRG
Vitalconnect, Inc.
Cardiovascular · 122d
Cleared Mar 07, 2019
Bonebridge
K183373 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 91d
Cleared Mar 07, 2019
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
K183551 · LON
bioMerieux, Inc.
Microbiology · 77d
Cleared Mar 07, 2019
Duo Lumbar Interbody Fusion Device
K190055 · MAX
Spineology, Inc.
Orthopedic · 55d
Cleared Mar 07, 2019
Endophys Pressure Sensing Sheath
K190098 · DYB
Endophys Holdings, LLC
Cardiovascular · 44d
Cleared Mar 07, 2019
HANAROSTENT LowAx Colon/Rectum (NNN)
K190141 · MQR
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 37d
Cleared Mar 07, 2019
iSLEEVE Introducer Set
K190184 · DYB
Boston Scientific
Cardiovascular · 34d