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
161521–161544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1981
PAN SET
K813437 · FRG
Sterile Design, Inc.
General Hospital · 23d
Cleared Dec 31, 1981
PIPERACILLIN 100 MCG. SENSI DISC
K813441 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Dec 31, 1981
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR
K813447 · JIS
Rna Medical Corp.
Chemistry · 30d
Cleared Dec 31, 1981
PHE/TYR KINETIC UV TEST SET
K813449 · JNB
P-L Biochemicals, Inc.
Chemistry · 21d
Cleared Dec 31, 1981
FREE T4 RIA TEST SET
K813465 · CEC
Ventrex Laboratories, Inc.
Chemistry · 20d
Cleared Dec 31, 1981
LIPID PROFILE
K813469 · CFD
Bio-Analytics Laboratories, Inc.
Chemistry · 20d
Cleared Dec 31, 1981
OHIO VOLUME INCENTIVE SPIROMETER
K813476 · BWF
Airco/Ohio Medical Products
Anesthesiology · 30d
Cleared Dec 31, 1981
CATHETER BUBBLE STAND
K813487 · FKX
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Dec 31, 1981
CATHETER REGULAR
K813488 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Dec 31, 1981
WATERS ILEAL RESERVOIR CATHETER
K813494 · KPH
Waters Instruments, Inc.
Gastroenterology & Urology · 17d
Cleared Dec 31, 1981
ALT (SGPT)
K813495 · CKA
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Dec 31, 1981
LDH-L
K813496 · CFJ
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Dec 31, 1981
FLAME PHOTOMETER CALIBRATION STANDARDS
K813505 · JIS
Fisher Scientific Co., LLC
Chemistry · 16d
Cleared Dec 31, 1981
METRONIDAZOLE DIAGNOSTIC DISCS
K813509 · JTO
Oxoid U.S.A., Inc.
Microbiology · 16d
Cleared Dec 31, 1981
URIC-ACID
K813511 · KNK
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Dec 31, 1981
AFRICAN GREEN MONKEY BLOOD IN ALSERVERS
K813513 · LHW
Dutchland Laboratories, Inc.
Pathology · 16d
Cleared Dec 31, 1981
BLOOD GAS ANALYSIS, STANDARDS CONTROLS
K813517 · CHL
United Diagnostics, Inc.
Chemistry · 15d
Cleared Dec 31, 1981
ELECTRIC SELF STERILIZATION INOCUL. LOOP
K813523 · LTB
Techhnilab Instruments, Inc.
Toxicology · 15d
Cleared Dec 31, 1981
CENTIDISC
K813524 · JQC
Bel-Art Products
Chemistry · 15d
Cleared Dec 31, 1981
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY
K813525 · JLW
Micromedic Systems
Chemistry · 15d
Cleared Dec 31, 1981
DADE COLORIMETRIC AMYLASE
K813529 · CIJ
American Dade
Chemistry · 14d
Cleared Dec 31, 1981
ASTRA TOTAL PROTEIN REAGENT
K813536 · CEK
Hi Chem, Inc.
Chemistry · 13d
Cleared Dec 31, 1981
PHENYTOIN FLUORESCENT IMMUNOASSAY
K813538 · LES
American Diagnostic Corp.
Toxicology · 10d
Cleared Dec 31, 1981
GENTAMICIN FLUORESCENT IMMUNOASSAY
K813539 · LCQ
American Diagnostic Corp.
Toxicology · 10d