FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77473–77496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2001
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
K011536 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 180d
Cleared Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K012738 · GEY
Depuyacromed
General & Plastic Surgery · 90d
Cleared Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
ICE BATON
K012746 · LKX
Behive, Ltd.
Gastroenterology & Urology · 90d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750 · MQB
Agfa Corp.
Radiology · 90d
Cleared Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
K012751 · MQV
Orquest, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
K012771 · GCJ
Pajunk GmbH
General & Plastic Surgery · 89d
Cleared Nov 14, 2001
N2000 BASE STATION, N2001 NURSE STATION
K012801 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 85d
Cleared Nov 14, 2001
CAROTID GUIDING SHEATH
K012812 · DYB
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Nov 14, 2001
MODIFICATION TO HANDMASTER
K012823 · GZI
Ness-Neuromuscular Electrical...
Neurology · 90d
Cleared Nov 14, 2001
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
K012882 · EBI
Thermoelastic Technologies, Inc.
Dental · 78d
Cleared Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283 · MOB
Immuno Concepts, Inc.
Immunology · 43d
Cleared Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285 · MOB
Immuno Concepts, Inc.
Immunology · 43d
Cleared Nov 14, 2001
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013291 · NCS
Advanced Diagnostics, Inc.
Radiology · 43d
Cleared Nov 14, 2001
VISULAS 532S
K013402 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 30d
Cleared Nov 14, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · MNI
Endius, Inc.
Orthopedic · 30d
Cleared Nov 14, 2001
MODIFICATION TO M2376A DEVICELINK SYSTEM
K013470 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 27d
Cleared Nov 14, 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · MQV
DePuy Orthopaedics, Inc.
Orthopedic · 221d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 90d
Cleared Nov 13, 2001
SORING GMBH SONOCA 180/190
K012753 · LFL
Soring GmbH Medizintechnik
General & Plastic Surgery · 89d
Cleared Nov 13, 2001
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · LYY
Kimberly-Clark Corp.
General Hospital · 83d
Cleared Nov 13, 2001
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · LHI
Alaris Medical Systems, Inc.
General Hospital · 57d
Cleared Nov 13, 2001
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · JIY
Wiener Laboratories Saic
Chemistry · 57d