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
162865–162888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1981
PLA-MATE
K803071 · GKL
Labex, Inc.
Chemistry · 231d
Cleared Jul 24, 1981
ELECTRONIC MUSCLE STIMULATOR
K811250 · IPF
Electrola
Physical Medicine · 80d
Cleared Jul 24, 1981
STIMULATOR, FACIAL-MODELS SF-100 & 200
K811502 · IPF
Rcx-Western, Inc.
Physical Medicine · 58d
Cleared Jul 24, 1981
R & S SERIES FITTING TOOLS
K811889 · EIC
Suncoast Dental Corp.
Dental · 23d
Cleared Jul 24, 1981
R & S SERIES IMPLANTS
K811923 · DZE
Suncoast Dental Corp.
Dental · 22d
Cleared Jul 23, 1981
PHADEBAS IGG RAST TEST
K810694 · DEW
Pharmacia, Inc.
Immunology · 129d
Cleared Jul 23, 1981
LABTRONIX PLATELET COUNTER(L/O/C.)
K811084 · GLG
Labtronix Corp.
Radiology · 93d
Cleared Jul 23, 1981
BASE METAL ALLOY
K811258 · EJH
Dentsply Intl.
Dental · 79d
Cleared Jul 23, 1981
ANTIBODY TO CHLAMYDIA TRACHOMATIS
K811570 · GPW
Electro-Nucleonics Laboratories, Inc.
Microbiology · 49d
Cleared Jul 23, 1981
ACCUDEX
K811680 · JJQ
Biodynamics Corp.
Chemistry · 38d
Cleared Jul 23, 1981
MODEL 4100 14 MEV NEUTRON GEN. THERAPY
K811778 · IWL
The Cyclotron Corp.
Radiology · 30d
Cleared Jul 23, 1981
UROPAPER EIKEN UAG
K811818 · JIL
Syn-Kit, Inc.
Microbiology · 27d
Cleared Jul 23, 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
K811850 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K811881 · CIG
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE TEST
K811882 · CGA
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE-O TEST
K811883 · CGE
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
CESIUM DILUENT 7.5M
K811886 · JGT
Gilford Diagnostics
Chemistry · 22d
Cleared Jul 23, 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · BTR
Mallinckrodt Critical Care
Anesthesiology · 22d
Cleared Jul 23, 1981
902 NA/K
K811896 · JGS
Corning Medical & Scientific
Chemistry · 22d
Cleared Jul 23, 1981
CENTURY LIFT TRANSFER SYSTEM
K811899 · FSA
Century Manufacturing Co.
General Hospital · 22d
Cleared Jul 23, 1981
CENTURY BATHING SYSTEM
K811901 · FNG
Century Manufacturing Co.
General Hospital · 22d
Cleared Jul 23, 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · CGJ
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
DHEA-SULFATE DIRECT RIA KIT(125I)
K811906 · JKC
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · JLS
Immunalysis Corporation
Chemistry · 22d