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
76969–76992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT....
K013102 · JMO
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 13, 2001
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
K013133 · MOQ
Nordix, Inc.
General & Plastic Surgery · 55d
Cleared Nov 13, 2001
SCANTAC MEMBRANE OR SCANTAC STRIP
K013170 · ITX
Sonotech, Inc.
Radiology · 50d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 13, 2001
AUTOJECT 2
K013362 · KZH
Owen Mumford USA, Inc.
General Hospital · 34d
Cleared Nov 13, 2001
MODEL MES-9000/EMG SYSTEM
K013399 · HCC
Myotronics-Noromed, Inc.
Neurology · 29d
Cleared Nov 13, 2001
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL...
K013603 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
K013604 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
K013633 · IYO
Toshiba America Medical Systems, In.C
Radiology · 8d