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
127513–127536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1990
RADIO-TEMP THERMOMETER
K896959 · FLL
Babymed Intl., Inc.
General Hospital · 82d
Cleared Mar 06, 1990
BLOOD PRESSURE CUFF
K896986 · DXQ
Latex Medical Devices, Inc.
Cardiovascular · 85d
Cleared Mar 06, 1990
IMMUNOTECH CHOLESTEROL TEST
K897036 · CHH
Immunotech Corp.
Chemistry · 78d
Cleared Mar 06, 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · DRT
Datex Division Instrumentarium Corp.
Cardiovascular · 75d
Cleared Mar 06, 1990
SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
K897082 · DQY
Schneider Intl., Ltd.
Cardiovascular · 76d
Cleared Mar 06, 1990
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031 · KNY
Porges Corp.
Gastroenterology & Urology · 61d
Cleared Mar 06, 1990
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
K900077 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 61d
Cleared Mar 06, 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · JPA
Baxter Healthcare Corp
Hematology · 39d
Cleared Mar 06, 1990
FACTOR V DEFICIENT PLASMA
K900406 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VII DEFICIENT PLASMA
K900407 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VIII DEFICIENT PLASMA
K900408 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR IX DEFICIENT PLASMA
K900409 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR X DEFICIENT PLASMA
K900410 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XI DEFICIENT PLASMA
K900411 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XII DEFICIENT PLASMA
K900412 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
OSTEONICS CEMENT RESTRICTOR
K900462 · JDK
Osteonics Corp.
Orthopedic · 34d
Cleared Mar 06, 1990
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
K900605 · DTD
Possis Medical, Inc.
Cardiovascular · 26d
Cleared Mar 06, 1990
ALPHA URINE SAMPLE
K900626 · DIF
Toxi-Lab, Inc.
Chemistry · 26d
Cleared Mar 06, 1990
MODIFIED CAPTIA(R) TOXO-M
K900655 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 25d
Cleared Mar 06, 1990
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · DDG
Reagents Applications, Inc.
Chemistry · 8d
Cleared Mar 06, 1990
FACTOR II DEFICIENT PLASMA
K900906 · GJT
Sigma Chemical Co.
Hematology · 7d
Cleared Mar 05, 1990
EXMOOR BITE BUFFER
K893006 · EOQ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 315d
Cleared Mar 05, 1990
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
K894259 · HIG
Washington Regulatory Services
Obstetrics & Gynecology · 258d
Cleared Mar 05, 1990
FRANK MILK PUMP
K895114 · HGX
Buttner-Frank GmbH
Obstetrics & Gynecology · 202d