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
151081–151104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1984
DENTAL CHAIR
K843436 · KLC
Swedish Dental Products, Inc.
Dental · 23d
Cleared Sep 27, 1984
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ
K843452 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Sep 27, 1984
EMIT 700 PHENCYCLIDINE ASSAY
K843509 · LCM
Syva Co.
Toxicology · 21d
Cleared Sep 27, 1984
PROGRAMMABLE STIMULATOR 5326
K843718 · JOQ
Medtronic Vascular
Cardiovascular · 3d
Cleared Sep 26, 1984
THEOPHYLLINE KIT FLUORESCENCE POLARIZA-
K842585 · LER
Windsor Laboratories, Inc.
Toxicology · 85d
Cleared Sep 26, 1984
PHENYTOIN KIT FLUORESCENCE POLARIZATION
K842586 · LGR
Windsor Laboratories, Inc.
Immunology · 85d
Cleared Sep 26, 1984
C-SECTION TRAY
K842627 · KDD
Deroyal Industries, Inc.
General & Plastic Surgery · 82d
Cleared Sep 26, 1984
EMIT D.A.U. AMPHETAMINE ASSAY
K842674 · DKZ
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
EMIT D.A.U. BARBITURATE ASSAY
K842675 · DIS
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
EMIT D.A.U. METHADONE ASSAY
K842676 · DJR
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
EMIT D.A.U. OPIATE ASSAY
K842677 · DJG
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
SURGITEK RECONSTRUC-NIPPLE PROSTHESIS
K842748
Medical Engineering Corp.
General & Plastic Surgery · 75d
Cleared Sep 26, 1984
EMIT D.A.U. BENZODIAZEPINE ASSAY
K842815 · JXM
Syva Co.
Toxicology · 70d
Cleared Sep 26, 1984
ELECTRONIC EPILATOR TS-1
K843063 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 51d
Cleared Sep 26, 1984
BRIMFIELD CANNULATED MAGNETIC RETRIEVER
K843135 · FCC
Brimfield Scientific Instruments
Gastroenterology & Urology · 48d
Cleared Sep 26, 1984
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
K843184 · KLR
American Dade
Immunology · 44d
Cleared Sep 26, 1984
TRICON-P TIBIAL COMPONENT
K843241 · JWH
Richards Medical Co., Inc.
Orthopedic · 50d
Cleared Sep 26, 1984
TRICON M TIBIAL COMPONENT
K843242 · JWH
Richards Medical Co., Inc.
Orthopedic · 50d
Cleared Sep 26, 1984
ACCUSCREEN TSH
K843281 · JLW
Neometrics, Inc.
Chemistry · 37d
Cleared Sep 26, 1984
EMIT 700 CANNABINOID CALIBRATOR
K843420 · DLJ
Syva Co.
Toxicology · 26d
Cleared Sep 26, 1984
ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER
K843460 · JJQ
Varian Assoc., Inc.
Chemistry · 21d
Cleared Sep 26, 1984
EMIT 700 CALIBRATOR B
K843507 · DKB
Syva Co.
Toxicology · 20d
Cleared Sep 26, 1984
TRIGLYCERIDES GPO REAGENT
K843552 · CDT
Bio-Rad
Chemistry · 16d
Cleared Sep 25, 1984
DANIELL DBL PUNCTURE LASER LAPAROSCOPY
K842498 · HET
Laser Spectrum, Inc.
Obstetrics & Gynecology · 91d