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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83809–83832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1999
KAC-300 KNEE ARRAY COIL
K993719 · MOS
Mri Devices Corp.
Radiology · 23d
Cleared Nov 26, 1999
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · DXT
Medrad, Inc.
Cardiovascular · 22d
Cleared Nov 26, 1999
MAMEX
K993740 · IZH
Medical Systems Group
Radiology · 22d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
K993763 · IZI
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
K993765 · IZI
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Nov 26, 1999
QSC-300 SHOULDER ARRAY COILS
K993780 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Nov 24, 1999
IGA MININEPH ANTISERUM
K981786 · CFQ
The Binding Site, Ltd.
Immunology · 553d
Cleared Nov 24, 1999
ABL 735 ANALYZER
K991417 · CHL
Radiometer America, Inc.
Chemistry · 215d
Cleared Nov 24, 1999
NEW MULTIPLES REAGENT STRIPS
K992257 · JIR
Bayer Corp.
Chemistry · 141d
Cleared Nov 24, 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT...
K992264 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 141d
Cleared Nov 24, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · MID
Cogent Diagnotics , Ltd.
Immunology · 125d
Cleared Nov 24, 1999
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
K992682 · JEY
Medartis AG
Dental · 106d
Cleared Nov 24, 1999
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · JEY
Medartis AG
Dental · 106d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710 · JJY
Abbott Laboratories
Immunology · 105d
Cleared Nov 24, 1999
GEM PREMIER 3000
K992834 · CHL
Instrumentation Laboratory CO
Chemistry · 93d
Cleared Nov 24, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 90d
Cleared Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K992900 · JJY
Roche Diagnostics Corp.
Immunology · 86d
Cleared Nov 24, 1999
HYTAC
K992909 · EBF
Espe Dental AG
Dental · 86d
Cleared Nov 24, 1999
ENABLE ENDOSCOPIC BIPOLAR SCISSORS
K992996 · GEI
Enable Medical Corp.
General & Plastic Surgery · 78d
Cleared Nov 24, 1999
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC,...
K993071 · CBK
Puritan Bennett Corp.
Anesthesiology · 71d
Cleared Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV...
K993252 · MVN
CooperVision, Inc.
Ophthalmic · 57d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K993360 · JJY
Roche Diagnostics Corp.
Immunology · 49d
Cleared Nov 24, 1999
K-ASSAY C3
K993437 · CZW
Kamiya Biomedical Co.
Immunology · 43d