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
24409–24432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2018
COCET Digital Thermometer (Models...
K182652 · FLL
Kangfu Medical Equipment Factory
General Hospital · 57d
Cleared Nov 20, 2018
Telepack X LED
K182696 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 54d
Cleared Nov 20, 2018
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K182715 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 54d
Cleared Nov 20, 2018
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable...
K182931 · FRC
Steris Corporations
General Hospital · 29d
Cleared Nov 19, 2018
AI-ECG Platform
K180432 · DQK
Shenzhen Carewell Electronics., Ltd.
Cardiovascular · 272d
Cleared Nov 19, 2018
R3 Anteverted Liners
K182535 · MBL
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Nov 19, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K182654 · NGG
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 55d
Cleared Nov 19, 2018
Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke...
K182772 · GEI
Covidien
General & Plastic Surgery · 49d
Cleared Nov 16, 2018
SafeT T-Piece Resuscitator
K173373 · BTL
Ventlab, LLC
Anesthesiology · 385d
Cleared Nov 16, 2018
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
K180184 · NHA
Dentalpoint AG
Dental · 297d
Cleared Nov 16, 2018
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
K180343 · POV
Bonraybio Co., Ltd.
Hematology · 282d
Cleared Nov 16, 2018
InstruSafe(R) Sterilization Container
K180528 · KCT
Summit Medical, Inc.
General Hospital · 261d
Cleared Nov 16, 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use...
K180645 · LZA
Hartalega Sdn Bhd
General Hospital · 249d
Cleared Nov 16, 2018
HemoSphere Advanced Monitor, HemoSphere Pressure Cable
K180881 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 226d
Cleared Nov 16, 2018
PureFlex Arterial Cannulae
K180979 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 217d
Cleared Nov 16, 2018
IT-III active System
K181137 · DZE
Neobiotech Co., Ltd.
Dental · 200d
Cleared Nov 16, 2018
Axis Chena Cervical PEEK Spacer System
K181140 · ODP
Axis Orthopaedics
Orthopedic · 200d
Cleared Nov 16, 2018
Oral Device OA, Oral Device S
K181396 · LRK
Passion For Life Healthcare (Uk) Limited
Dental · 171d
Cleared Nov 16, 2018
SmartBag (SmartPouch)
K181643 · EXB
11 Health Technologies Limited
Gastroenterology & Urology · 147d
Cleared Nov 16, 2018
Celesteion, PCA-9000A/3, V6.5
K181646 · JAK
Canon Medical Systems Corporation
Radiology · 147d
Cleared Nov 16, 2018
Serenity Piezo Sensor, Serenity Thermocouple Sensor
K181709 · OLV
Neurotronics, Inc.
Neurology · 141d
Cleared Nov 16, 2018
Solidity Vertebral Body Replacement
K181921 · MQP
Ulrich Medical USA
Orthopedic · 121d
Cleared Nov 16, 2018
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K181948 · MOS
Rapid Biomedical GmbH
Radiology · 119d
Cleared CT Nov 16, 2018
AposTherapy System
K182090 · QDT
Apos Medical Assets , Ltd.
Physical Medicine · 106d