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
15793–15816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2021
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM...
K212511 · GCJ
Stryker
General & Plastic Surgery · 86d
Cleared Nov 04, 2021
IPL Hair Removal Device, model: AI01
K212897 · OHT
Shenzhen Century Dongyuan Technology...
General & Plastic Surgery · 55d
Cleared Nov 04, 2021
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All...
K212912 · MAI
B-One Ortho, Corp.
Orthopedic · 52d
Cleared Nov 04, 2021
Dakota ALIF Plate System
K212937 · KWQ
Precision Spine, Inc.
Orthopedic · 50d
Cleared Nov 03, 2021
BD Kiestra IdentifA
K191964 · QQV
Becton, Dickinson and Company
Microbiology · 834d
Cleared Nov 03, 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320 · KFM
Qura S.R.L
Cardiovascular · 534d
Cleared Nov 03, 2021
SOL-CARE IV Bag Safety Connector
K202732 · LHI
Sol-Millennium Medical Group
General Hospital · 411d
Cleared Nov 03, 2021
SyMRI
K203372 · LNH
Syntheticmr AB
Radiology · 352d
Cleared Nov 03, 2021
LELTEK Ultrasound Imaging System (Model: LU700 Series)
K210432 · IYN
Leltek, Inc.
Radiology · 264d
Cleared Nov 03, 2021
IM007
K210543 · DQK
Implicity, Inc.
Cardiovascular · 252d
Cleared Nov 03, 2021
Nulife
K210969 · KGO
Mrk Healthcare Pvt, Ltd.
General Hospital · 217d
Cleared Nov 03, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
K211544 · HAW
Brainlab AG
Neurology · 168d
Cleared Nov 03, 2021
GlideScope BFlex 2.8 Single-Use Bronchoscope
K211947 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 133d
Cleared Nov 03, 2021
Fetal Doppler
K212084 · KNG
Shenzhen Mericonn Technology Co., Ltd.
Obstetrics & Gynecology · 124d
Cleared Nov 03, 2021
FLUME catheter
K212151 · EZL
The Flume Catheter Company, Ltd.
Gastroenterology & Urology · 117d
Cleared Nov 03, 2021
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 112d
Cleared Nov 03, 2021
S.I.N. Instrument Kits
K212404 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 93d
Cleared Nov 03, 2021
NuVasive Anterior Cervical Plate Systems
K212446 · KWQ
Nu Vasive, Incorporated
Orthopedic · 90d
Cleared Nov 03, 2021
MOVIX DReamy
K212515 · IZL
Stephanix
Radiology · 85d
Cleared Nov 03, 2021
REAL INTELLIGENCE CORI (CORI)
K212537 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 83d
Cleared Nov 02, 2021
Disposable Medical Mask
K210222 · FXX
Guangdong Lide Medical Technology...
General Hospital · 278d
Cleared Nov 02, 2021
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF,...
K210473 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 258d
Cleared Nov 02, 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
K210598 · PIF
Cair Lgl
Gastroenterology & Urology · 246d
Cleared Nov 02, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210777 · LZA
Shandong Jieshi Medical Products Co.,...
General Hospital · 232d