FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128017–128040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1989
CALCIUM, CATALOGUE NUMBER140-20
K895873 · CJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Dec 12, 1989
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936 · JGS
Medica Corp.
Chemistry · 62d
Cleared Dec 12, 1989
CHOLESTEROL, UNIVERSAL ET
K896073 · CHH
Enzyme Technology, Inc.
Chemistry · 54d
Cleared Dec 12, 1989
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270 · CHP
Amersham Corp.
Chemistry · 42d
Cleared Dec 12, 1989
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K896329 · KLI
Photec Diagnostics, Inc.
Chemistry · 40d
Cleared Dec 12, 1989
KONTRON KOLORMON 7250 PATIENT MONITOR
K896417 · DPS
Kontron Instruments, Inc.
Cardiovascular · 34d
Cleared Dec 12, 1989
MODIFIED CEDIA(TM) CORTISOL ASSAY
K896451 · CGR
Microgenics Corp.
Chemistry · 33d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892091 · LYY
Rising Crown Industries , Ltd.
General Hospital · 252d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892636 · LYY
P.T. Latexindo Parama
General Hospital · 245d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVE/MANUF. KUN SHAN FACTORY
K893513 · LYY
Pioneer Sundries Products , Ltd.
General Hospital · 220d
Cleared Dec 11, 1989
SPRING LATEX EXAMINATION GLOVES
K894213 · LYY
Brandywine Surgical, Inc.
General Hospital · 175d
Cleared Dec 11, 1989
LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.)
K895637 · LYY
Transcontinental Fertilizer Co.
General Hospital · 83d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVES (NON STERILE)
K895657 · LYY
Ka Hung Development , Ltd.
General Hospital · 82d
Cleared Dec 11, 1989
PAP SMEAR TRAY
K895675 · HHT
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 82d
Cleared Dec 11, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · LLM
Immuno Concepts, Inc.
Microbiology · 77d
Cleared Dec 11, 1989
PRESSURE STEAM STERILIZERS
K895848 · FLE
Scientific Device Laboratory, Inc.
General Hospital · 69d
Cleared Dec 11, 1989
GLOVE N GEL
K896306 · LYY
Ems Medical, Inc.
General Hospital · 42d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
K896334 · LCP
Creative Laboratory Products, Inc.
Hematology · 38d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
K896335 · LCP
Creative Laboratory Products, Inc.
Hematology · 38d
Cleared Dec 11, 1989
WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES
K896399 · LYY
Prime Horizon, Inc.
General Hospital · 34d
Cleared Dec 11, 1989
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
K896625 · GJS
Medical Diagnostic Technologies, Inc.
Hematology · 20d
Cleared Dec 08, 1989
LORD L.F.R. TOTAL HIP SYSTEM
K884890 · JDI
Howmedica Corp.
Orthopedic · 381d
Cleared Dec 08, 1989
RECTUM-COLON MOTILITY MONITOR
K884920 · FAP
Multi-Spectrum Consulting, Inc.
Gastroenterology & Urology · 375d
Cleared Dec 08, 1989
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
K894068 · HSX
Kirschner Medical Corp.
Orthopedic · 183d