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
169201–169224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1979
PISCES-SELECTOR X
K790790 · GZB
Medtronic Vascular
Neurology · 31d
Cleared May 25, 1979
PURGE LINE UNIT
K790804 · DTL
Surgikos, Inc.
Cardiovascular · 31d
Cleared May 25, 1979
DISPOSA-CUF
K790810 · DXQ
Crest Medical Equipment
Cardiovascular · 29d
Cleared May 25, 1979
EGS MODEL 300
K790847 · IPF
Alfred V. Greco
Physical Medicine · 21d
Cleared May 25, 1979
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868 · DXY
Telectronics, Inc.
Cardiovascular · 18d
Cleared May 24, 1979
TERUMO IMUGARD
K790105 · GKT
Terumo America, Inc.
Hematology · 128d
Cleared May 23, 1979
CONCEP-7-B-HCG
K790397 · JHI
Leeco Diagnostics, Inc.
Chemistry · 86d
Cleared May 23, 1979
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524 · CKE
Data Medical Associates, Inc.
Chemistry · 69d
Cleared May 23, 1979
ELECTRODES, STAODERM STERILE
K790542 · GXY
Staodynamics, Inc.
Neurology · 62d
Cleared May 23, 1979
STIMULATOR, NIC-106 VISUAL
K790570 · GWE
Nicolet Biomedical Instruments
Neurology · 61d
Cleared May 23, 1979
CENTRIFICHEM FILTER CALIBRATION SET
K790643 · JIW
Union Carbide Corp.
Chemistry · 54d
Cleared May 23, 1979
HELENA QUIPLATE SYSTEM
K790646 · JZQ
Helena Laboratories
Immunology · 54d
Cleared May 23, 1979
VENOUS PRESSURE MONITOR, MF 35 LF
K790668 · KRK
Deco Medical, Inc.
Cardiovascular · 47d
Cleared May 23, 1979
ESTRADIOL RIA KIT
K790679 · CHP
Serono Laboratories, Inc.
Chemistry · 44d
Cleared May 23, 1979
ENZYMATIC DETERMINATION
K790724 · CHH
Sigma Chemical Co.
Chemistry · 40d
Cleared May 23, 1979
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
K790760 · CHH
Sigma Chemical Co.
Chemistry · 36d
Cleared May 23, 1979
IMMU-TEK AUTOMATIC CENTRIFUGE
K790767 · KSN
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 34d
Cleared May 23, 1979
WAKO CHOLESTEROL TEST
K790768 · CHH
Wako Intl., Inc.
Chemistry · 34d
Cleared May 23, 1979
DADE LOW IONIC STRENGTH SOLUITION (LISS)
K790776 · KSG
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 33d
Cleared May 23, 1979
ENTERIC TUBE GUIDE
K790872 · FZX
Biosearch Medical Products, Inc.
General & Plastic Surgery · 16d
Cleared May 23, 1979
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
K790877 · JDY
Stackhouse Assoc.
Orthopedic · 16d
Cleared May 23, 1979
BACTEC
K790899 · KLP
Bd Becton Dickinson Vacutainer...
Toxicology · 14d
Cleared May 23, 1979
D.T.T. LOCK SCREW INSERTER
K790941 · KWQ
Depuy, Inc.
Orthopedic · 5d
Cleared May 22, 1979
QUANTAZYME TOXOPLASMA
K790360 · GLZ
Bio-Rad
Microbiology · 89d