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
165481–165504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
K802108 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
K802109 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
TESTOSTERONE RADIOIMMUNOASSY KIT
K802135 · CDZ
Radioimmunoassay, Inc.
Chemistry · 36d
Cleared Oct 10, 1980
DELTA TEST TRIGLYCERIDES
K802136 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K802141 · JPK
American Dade
Hematology · 35d
Cleared Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K802142 · JPK
American Dade
Hematology · 35d
Cleared Oct 10, 1980
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K802143 · JPK
American Dade
Hematology · 35d
Cleared Oct 10, 1980
AQUASONIC 100 ULTRASOUND TRANS. GEL,
K802146 · IYO
Parker Laboratories, Inc.
Radiology · 35d
Cleared Oct 10, 1980
REAGENTS USED-QUAN. MEASURE OF SERUM
K802154 · CIG
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
REAGENTS SERUM SODIUM USING THE TECH.
K802155 · JGS
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
REAGENTS SERUM CREATINE USING TECHICON
K802156 · CGX
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BCG REAGENT SERUM ALBUMIN W/TECHNICON
K802157 · CIX
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
POSTASSIUM BUFFER SOL. & WASH SOLUTION
K802158 · CEM
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS
K802159 · CEO
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BUN COLOR REAGENT & BUN ACID USED
K802160 · CDW
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
BIURET REAGENT & TOTAL PROTEIN BLANK SOL
K802161 · CEK
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
K802162 · KMS
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT
K802163 · CHJ
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.
K802164 · CIC
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
MINOCYCLINE 30 MCG. SENSITIVITY DISCS
K802178 · JTN
Difco Laboratories, Inc.
Microbiology · 31d
Cleared Oct 10, 1980
ARTERIAL BLOOD SAMPLING KIT
K802185 · FMP
Current Technologies, Inc.
Hematology · 30d
Cleared Oct 10, 1980
WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802213 · KKX
G.D. Searle and Co.
General Hospital · 28d
Cleared Oct 10, 1980
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · KWQ
Zimmer, Inc.
Orthopedic · 28d
Cleared Oct 10, 1980
AIR VIVA II
K802231 · BTM
General Medical Co.
Anesthesiology · 25d