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
77641–77664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2001
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 400d
Cleared Sep 06, 2001
UROSCOPE, ARTES MEDICAL, USA
K003988 · FAJ
Artes Medical USA, Inc.
Gastroenterology & Urology · 254d
Cleared Sep 06, 2001
LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
K010431 · GXY
Lead-Lok, Inc.
Neurology · 205d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · NGU
Cook, Inc.
General & Plastic Surgery · 203d
Cleared Sep 06, 2001
VECTORVISION KNEE
K010612 · HAW
Brainlab AG
Neurology · 189d
Cleared Sep 06, 2001
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS,...
K011128 · CIB
Nichols Institute Diagnostics
Chemistry · 146d
Cleared Sep 06, 2001
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
K011361 · DRF
Catheffects, LLC
Cardiovascular · 126d
Cleared Sep 06, 2001
NEUROTHERM, MODEL JK4
K011387 · GXI
Eurolink, LLC
Neurology · 122d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · KTW
Synthes (Usa)
Orthopedic · 87d
Cleared Sep 06, 2001
STERILE EMG ELECTRODES
K011818 · IKT
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · HWC
New Deal, S.A.
Orthopedic · 87d
Cleared Sep 06, 2001
BIOREHAB SYSTEM
K011823 · HCC
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875 · JDW
New Deal, S.A.
Orthopedic · 83d
Cleared Sep 06, 2001
OPTIBOND SOLO PLUS 3
K011908 · EBC
Kerr Dental Materials Center
Dental · 79d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · DQY
Guidant Corp.
Cardiovascular · 66d
Cleared Sep 06, 2001
3.25MM SPLINE TWIST IMPLANT
K012055 · DZE
Sulzer Dental, Inc.
Dental · 66d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · KHS
Jas Diagnostics, Inc.
Chemistry · 45d
Cleared Sep 06, 2001
LC TEMPORARY FILLING
K012360 · EBG
Parkell, Inc.
Dental · 43d
Cleared Sep 06, 2001
PANAVIA F
K012441 · EMA
Kuraray Medical, Inc.
Dental · 37d
Cleared Sep 06, 2001
VERASTEP
K012539 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 30d
Cleared Sep 06, 2001
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K012564 · HAW
Brainlab AG
Neurology · 28d
Cleared Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · KPS
General Electric Co.
Radiology · 28d
Cleared Sep 06, 2001
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
K012584 · CAZ
Bd
Anesthesiology · 27d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · JJT
Bio-Rad
Chemistry · 24d