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
124465–124488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1990
MODEL MD-5 DOPPLER
K901592 · DXK
D. E. Hokanson, Inc.
Cardiovascular · 200d
Cleared Oct 22, 1990
FETAL PULSE DETECTOR MODEL DOP-1
K902190 · HEK
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 159d
Cleared Oct 22, 1990
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · IPF
Chattanooga Group, Inc.
Physical Medicine · 132d
Cleared Oct 22, 1990
SPO2 OPTION
K902730 · DQA
Protocol Systems, Inc.
Anesthesiology · 123d
Cleared Oct 22, 1990
TROPI-COOL
K902756 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 122d
Cleared Oct 22, 1990
ROZINN 151
K903331 · DSH
Rozinn Electronics, Inc.
Cardiovascular · 89d
Cleared Oct 22, 1990
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 22, 1990
OSTEOLOCK(TM) ACETABULAR CUP
K903362 · JDI
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 22, 1990
SOEHENDRA STENT RETRIEVER
K903420 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 22, 1990
LIFECOIL CATHETER
K903502 · FJS
Lifemed of California
Gastroenterology & Urology · 80d
Cleared Oct 22, 1990
PERCUTANEOUS INTRODUCERS
K903530 · DYB
Davol, Inc.
Cardiovascular · 77d
Cleared Oct 22, 1990
KEJUMP DIGITAL CLINICAL THERMOMETER
K903590 · FLL
K-Jump Health Co., Ltd.
General Hospital · 75d
Cleared Oct 22, 1990
SEROTONIN ENZYME IMMUNOASSAY
K903609 · CDA
Immunotech Corp.
Chemistry · 74d
Cleared Oct 22, 1990
PATIENT EXAMINATION GLOVES
K903703 · LYY
P.T. Tulip Indah Agung
General Hospital · 68d
Cleared Oct 22, 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · KFF
Organon Teknika Corp.
Hematology · 62d
Cleared Oct 22, 1990
TARGET(TM) HOG ONE STEP
K903937 · JHI
V-Tech, Inc.
Chemistry · 56d
Cleared Oct 22, 1990
COAGULATION REFERENCE PLASMA, ABNORMAL
K904073 · GGC
Medi-Tech, Inc.
Hematology · 47d
Cleared Oct 22, 1990
AMK MODULAR TIBIAL WEDGE SYSTEM
K904205 · JWH
Depuy, Inc.
Orthopedic · 40d
Cleared Oct 22, 1990
SYNCHRON CX 7 CLINICAL ANALYZER
K904219 · JJE
Beckman
Chemistry · 40d
Cleared Oct 22, 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292 · CGA
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 22, 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414 · DSP
Datascope Corp.
Cardiovascular · 63d
Cleared Oct 19, 1990
AMUKIN 50% - AIRSPRAY(R)
K885037 · FKO
Bernard J. Cooney, P.A.
Gastroenterology & Urology · 683d
Cleared Oct 19, 1990
MODIFIED INTRAVENOUS CATHETER
K896813 · FOZ
Safeguard Needle Co.
General Hospital · 319d
Cleared Oct 19, 1990
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · KRB
Intec Medical, Inc.
Cardiovascular · 247d