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
156697–156720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1983
COMPLUS VARIOUS FORMS
K831039
Parker Laboratories, Inc.
Dental · 57d
Cleared May 27, 1983
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · CGR
Syva Co.
Immunology · 50d
Cleared May 27, 1983
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178 · CJM
Diagnostic Products Corp.
Chemistry · 46d
Cleared May 27, 1983
PREGNA-CERT, SLIDE PREGNANCY TEST
K831180 · JHJ
Diagnostic Specialties
Chemistry · 46d
Cleared May 27, 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · DYG
Cook, Inc.
Cardiovascular · 45d
Cleared May 27, 1983
GAS-STAT MONITORING SYSTEM
K831225 · DRY
Cardiovascular Devices, Inc.
Cardiovascular · 42d
Cleared May 27, 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · KLS
Syva Co.
Chemistry · 38d
Cleared May 27, 1983
LIQUI-SERA ANTICONVULSANTS CONTROLS
K831278 · DIF
Biodiagnostic Intl
Toxicology · 38d
Cleared May 27, 1983
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K831324 · GWQ
Nihon Kohden America, Inc.
Neurology · 32d
Cleared May 27, 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
K831338 · KOC
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared May 27, 1983
FLUID ADMIN. SET AFS-1C
K831348 · DRS
Linton Biomed Corp.
Cardiovascular · 32d
Cleared May 27, 1983
EMIT QST LIDOCAINE ASSAY
K831354 · KLR
Syva Co.
Toxicology · 31d
Cleared May 27, 1983
TESTCORP CRP
K831362 · DCN
Catheter Technology Corp.
Microbiology · 31d
Cleared May 27, 1983
TESTCORP RA
K831364 · DCN
Myo-Tronics Research, Inc.
Microbiology · 31d
Cleared May 27, 1983
LATEX URINARY CATHETERS
K831369 · KOD
Wayne Surgical Products
Gastroenterology & Urology · 31d
Cleared May 25, 1983
MYCOPLASMELISA TEST KIT
K823804 · LJZ
M.A. Bioproducts
Microbiology · 159d
Cleared May 25, 1983
MODEL 515 NEO-TRAK NEONATAL MONITOR
K823904 · DRT
Ge Medical Systems Information...
Cardiovascular · 148d
Cleared May 25, 1983
BERA SH 221 BRIAN STEM AUDIOMETER
K830173 · GNJ
Jedmed Instrument Co.
Microbiology · 127d
Cleared May 25, 1983
OMNISTICK
K830310 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 119d
Cleared May 25, 1983
AUTO STIK
K830311 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 119d
Cleared May 25, 1983
ASPIRATOR
K830312 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 119d
Cleared May 25, 1983
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · JDI
Biomet, Inc.
Orthopedic · 114d
Cleared May 25, 1983
FIRST AID BAGS #1,2,3
K830375 · FRO
Akla, Inc.
General & Plastic Surgery · 110d
Cleared May 25, 1983
RECORDER DMI
K830489 · DSH
Diagnostic Medical Instruments
Cardiovascular · 99d