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
156769–156792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1983
MODIFIED NEW YORK MEDIUM
K831359 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared May 18, 1983
MODEL ND1100 BONE DENSITY SCANNER
K837230
Molsgaard Medical
Radiology · 12d
Cleared May 18, 1983
SHARPLAN 721 CO2 SURGICAL LASER
K837342
Laser Industries , Ltd.
Radiology · 71d
Cleared May 18, 1983
OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM
K837378
Omnimedical
Radiology · 62d
Cleared May 18, 1983
AUTO D OPTION
K837430
Technicare Corp.
Radiology · 19d
Cleared May 17, 1983
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177 · KXT
American Dade
Immunology · 36d
Cleared May 16, 1983
LUS ACETABULAR COMPONENT
K830209 · JDI
Biomet, Inc.
Orthopedic · 112d
Cleared May 16, 1983
DIFF 4 SYSTEM
K830441 · EKZ
Coulter Electronics, Inc.
Hematology · 95d
Cleared May 16, 1983
PLATELET AGGREGOMETER
K830749 · JBX
Chrono-Log Corp.
Hematology · 68d
Cleared May 16, 1983
SYRINGE 500BC BE #7000
K830898 · BXW
Instrumentation Industries, Inc.
Anesthesiology · 56d
Cleared May 16, 1983
OCUCARE PACK
K830902 · HQC
Ocular Innovations, Inc.
Ophthalmic · 56d
Cleared May 16, 1983
EXTRELUT QE EXTRACTION COLUMNS
K831027 · KEA
Emd Chemicals, Inc.
Toxicology · 47d
Cleared May 16, 1983
CHEMONUCLEOLYSIS TABLE EXTENSION
K831042 · FSE
Orthopedic Systems, Inc.
General & Plastic Surgery · 46d
Cleared May 16, 1983
EZEE FILTER/SEPARATOR
K831081 · JKA
The Kendall Company Div. of Tyco...
Chemistry · 42d
Cleared May 16, 1983
APELLO, PERSONAL HEALTH SUPPORT SYS.
K831093 · ILQ
Almicro Electronics, Inc.
Physical Medicine · 42d
Cleared May 16, 1983
CORDIA PAP
K831105 · JFH
Cordis Corp.
Immunology · 41d
Cleared May 16, 1983
OXYCOIL
K831146 · BYX
Channing Corp.
Anesthesiology · 38d
Cleared May 16, 1983
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
K831154 · LES
American Dade
Immunology · 38d
Cleared May 16, 1983
SPUNGUARD SCRUB SUIT
K831207 · FXO
Kimberly-Clark Corp.
General Hospital · 34d
Cleared May 16, 1983
GENTAMICIN CALIBRATOR -ACA
K831209 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared May 16, 1983
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K831226 · GEC
Ballard Medical Products
General & Plastic Surgery · 31d
Cleared May 16, 1983
LED GOGGLES
K831231 · HLX
Cadwell Laboratories, Inc.
Ophthalmic · 31d
Cleared May 16, 1983
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
K831242 · JKA
American Dade
Hematology · 31d
Cleared May 16, 1983
SAFE-SEAT WHEELCHAIR CUSHION
K831247 · KIC
D.A. Schulman, Inc.
Physical Medicine · 28d