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
19801–19824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2020
Kogent Torus Ultrasonic Aspirator
K192963 · LFL
Katalyst Surgical, LLC
General & Plastic Surgery · 240d
Cleared Jun 19, 2020
SpineFrontier Lumbar Interbody Fusion Device System
K193106 · MAX
Spinefrontier, Inc.
Orthopedic · 224d
Cleared Jun 19, 2020
BriefCase
K193298 · QAS
Aidoc Medical , Ltd.
Radiology · 205d
Cleared Jun 19, 2020
MPS 3 Myocardial Protection System
K200438 · DTR
Quest Medical, Inc.
Cardiovascular · 116d
Cleared Jun 19, 2020
Infrared Thermometer Model Number RN-60A,RN-60B
K200471 · FLL
Ningbo Ranor Medical Science &...
General Hospital · 114d
Cleared Jun 19, 2020
EksoNR
K200574 · PHL
Ekso Bionics, Inc.
Neurology · 106d
Cleared Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue...
K200671 · LZA
Ansell Healthcare Products, LLC
General Hospital · 98d
Cleared Jun 19, 2020
The NOxBOXi Nitric Oxide Delivery System
K201339 · MRN
Praxair, Inc.
Anesthesiology · 30d
Cleared Jun 19, 2020
AQUILA 320 D / AQUILA 320 S
K201340 · IZL
Vmi Tecnologias Ltda
Radiology · 30d
Cleared Jun 19, 2020
Multiflex Tinnitus Technology
K201370 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 18, 2020
BV Dental Implant System
K192274 · DZE
Bio Concept Co., Ltd.
Dental · 301d
Cleared Jun 18, 2020
Servo-air 4.0 Ventilator System
K192604 · CBK
Maquet Critica Care AB
Anesthesiology · 272d
Cleared Jun 18, 2020
NUVO IF Implant System
K193234 · DZE
Jjgc Industria E Comercio DE...
Dental · 206d
Cleared Jun 18, 2020
SIGNAFUSE Bioactive Bone Graft
K193513 · MQV
Bioventus
Orthopedic · 182d
Cleared Jun 18, 2020
OptoMonitor 3
K193620 · DXO
Opsens, Inc.
Cardiovascular · 175d
Cleared Jun 18, 2020
Medussa-PL Cage
K200283 · MAX
Medyssey USA, Inc.
Orthopedic · 135d
Cleared Jun 18, 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200297 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 133d
Cleared Jun 18, 2020
Giotto Class (Models - 3000X-YY and 4000X-YY)
K200424 · MUE
Ims Giotto S.P.A.
Radiology · 119d
Cleared Jun 18, 2020
Andorate Biopsy Valve, Andorate Biopsy Irrigator
K200481 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 112d
Cleared Jun 18, 2020
TENS and Muscle Stimulator
K200727 · NUH
Shenzhen Astec Technology Co., Ltd.
Neurology · 90d
Cleared Jun 18, 2020
Harvey(R) Surgical Assistant
K200892 · OLO
Orthalign, Inc.
Orthopedic · 76d
Cleared Jun 18, 2020
PF4 IgG assay
K201311 · LCO
Immucor Gti Diagnostics, Inc.
Hematology · 31d
Cleared Jun 18, 2020
NavLock Trackers
K201327 · OLO
Medtronic Navigation
Orthopedic · 30d
Cleared Jun 18, 2020
InPen System
K201337 · NDC
Companion Medical, Inc.
General Hospital · 29d