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
76105–76128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2002
UROVYSION BLADDER CANCER RECURRENCE KIT
K013785 · MMW
Vysis
Immunology · 86d
Cleared Feb 08, 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · HTN
Synthes (Usa)
Orthopedic · 85d
Cleared Feb 08, 2002
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
K013864 · GEX
Nidek, Inc.
General & Plastic Surgery · 79d
Cleared Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · LBS
Olympus America, Inc.
Chemistry · 65d
Cleared Feb 08, 2002
CARESIDE APTT
K014028 · GFO
Careside Hemotology, Inc.
Hematology · 64d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS...
K014032 · LBS
Olympus America, Inc.
Chemistry · 64d
Cleared Feb 08, 2002
PYLORITEK VP TEST KIT 5140VP
K014038 · LYR
Serim Research Corp.
Microbiology · 63d
Cleared Feb 08, 2002
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
K014120 · CDZ
Diagnostics Biochem Canada, Inc.
Chemistry · 53d
Cleared Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · MQG
Cook Urological, Inc.
Obstetrics & Gynecology · 51d
Cleared Feb 08, 2002
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
K020075 · DQA
Dolphin Medical, Inc.
Anesthesiology · 30d
Cleared Feb 08, 2002
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K020088 · GXN
Bioplate, Inc.
Neurology · 29d
Cleared Feb 08, 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096 · DZE
Institut Straumann AG
Dental · 28d
Cleared Feb 08, 2002
REPICCI II UNICONDYLAR KNEE SYSTEM
K020264 · HRY
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Feb 08, 2002
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
K020284 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 11d
Cleared Feb 07, 2002
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K002604 · DSI
Invivo Research, Inc.
Cardiovascular · 534d
Cleared Feb 07, 2002
FAST SET PUTTY
K012589 · GXP
Synthes (Usa)
Neurology · 181d
Cleared Feb 07, 2002
GELZONE
K013732 · MDA
Implantech Associates, Inc.
General & Plastic Surgery · 90d
Cleared Feb 07, 2002
PEACE OF MIND HOME DRUG TEST
K013778 · MVO
Advantage Diagnostics Corp.
Toxicology · 86d
Cleared Feb 07, 2002
D.SIGN 59
K013809 · EJS
Ivoclar Vivadent, Inc.
Dental · 84d
Cleared Feb 07, 2002
ENDOSCOPIC MULTI-FIRE CLIP APPLIER
K013889 · PKL
Inscope, LLC
Gastroenterology & Urology · 76d
Cleared Feb 07, 2002
HELIOMOLAR HB TRANSLUCENT SHADES
K013929 · EBF
Ivoclar Vivadent, Inc.
Dental · 71d
Cleared Feb 07, 2002
TASK FORCE MONITOR 3040
K014063 · DSB
Cnsystems Medizintechnik GmbH
Cardiovascular · 58d
Cleared Feb 07, 2002
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
K014144 · EBF
Afp Imaging Corp.
Dental · 51d
Cleared Feb 07, 2002
SMARTEPIL
K020107 · GEX
Cynosure, Inc.
General & Plastic Surgery · 27d