Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82537–82560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/EXPRESS 550
K001921 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 21, 2000
RESOLUTION CHOLESTEROL MONITOR
K000610 · CHH
Lifestream Technologies, Inc.
Chemistry · 149d
Cleared Jul 21, 2000
CALCIJECT
K001050 · EJK
Centrix, Inc.
Dental · 112d
Cleared Jul 21, 2000
ARIA
K001317 · MWJ
Del Mar Medical Systems, LLC
Cardiovascular · 86d
Cleared Jul 21, 2000
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · DSA
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
K001423 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
K001424 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
K001426 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 74d
Cleared Jul 21, 2000
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K001530 · JEY
Bioplate, Inc.
Dental · 65d
Cleared Jul 21, 2000
MINICAM
K001541 · EIA
Video Dental Concepts, Inc.
Dental · 65d
Cleared Jul 21, 2000
MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM
K001750 · LLZ
Barco NV Display Systems
Radiology · 43d
Cleared Jul 21, 2000
TAKE 1 BITE
K001876 · ELW
Sybron Dental Specialties, Inc.
Dental · 31d
Cleared Jul 21, 2000
MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K002046 · DXN
Vsm Technology, Inc.
Cardiovascular · 16d
Cleared Jul 21, 2000
PROTON BEAM THERAPY SYSTEM (PBTS)
K992414 · LHN
Optivus Technology, Inc.
Radiology · 367d
Cleared Jul 21, 2000
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510
K994141 · MJN
Medtronic Ave, Inc.
Cardiovascular · 226d
Cleared Jul 20, 2000
PTA BALLOON CATHETER
K001087 · LIT
Cook, Inc.
Cardiovascular · 107d
Cleared Jul 20, 2000
DR180-II
K001288 · MWJ
North East Monitoring, Inc.
Cardiovascular · 87d
Cleared Jul 20, 2000
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
K001306 · DQD
Andromed, Inc.
Cardiovascular · 86d
Cleared Jul 20, 2000
CPAP SYSTEM, MODEL 102001
K001318 · BYE
Sims Portex, Inc.
Anesthesiology · 85d
Cleared Jul 20, 2000
MODIFICATION TO OMEGA 21 SYSTEM
K001357 · KWQ
Ebi, L.P.
Orthopedic · 83d
Cleared Jul 20, 2000
TI-MAX PROTRUSIO CAGE
K001376 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Jul 20, 2000
SYNTHES CERVIFIX SYSTEM
K001864 · KWQ
Synthes Spine
Orthopedic · 30d
Cleared Jul 20, 2000
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS...
K001885 · CDN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d