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
79321–79344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2001
QUANTUM BLAST
K011993 · ITI
Pride Mobility Products Corp.
Physical Medicine · 17d
Cleared Jul 13, 2001
MEDICAL DEPOT POWER NEB 1
K012006 · CAF
Medical Depot, Inc.
Anesthesiology · 16d
Cleared Jul 13, 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Jul 12, 2001
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
K000265 · JOL
Primary Care Solutions, Inc.
General Hospital · 531d
Cleared Jul 12, 2001
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K000266 · JOL
Primary Care Solutions, Inc.
General Hospital · 531d
Cleared Jul 12, 2001
HA-TI (HAND TITANIUM SCREW) IMPLANT
K003045 · DZE
Hati Dental Ag.
Dental · 286d
Cleared Jul 12, 2001
IMMOBILIZATION SYSTEM FOR ENT
K003779 · IYE
Arplay Medical S.A.
Radiology · 217d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · MQV
Biocomposites, Ltd.
Orthopedic · 203d
Cleared Jul 12, 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · KXK
Ibt, Inc.
Radiology · 87d
Cleared Jul 12, 2001
TEMPORALSCANNER THERMOMETER, SENSORTOUCH
K011291 · FLL
Exergen Corp.
General Hospital · 76d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · KRH
Medtronic Vascular
Cardiovascular · 66d
Cleared Jul 12, 2001
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · DXF
NuMED, Inc.
Cardiovascular · 52d
Cleared Jul 12, 2001
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · EBI
Dentsply Intl.
Dental · 52d
Cleared Jul 12, 2001
PURESPERM BUFFER
K011606 · MQL
Nidacon International AB
Obstetrics & Gynecology · 49d
Cleared Jul 12, 2001
VACUETTE SAFETY BLOOD COLLECTION SET
K011786 · FMI
Greiner Vacuette North America, Inc.
General Hospital · 34d
Cleared Jul 12, 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · JJY
Bio-Rad
Chemistry · 28d
Cleared Jul 12, 2001
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE
K011925 · FMI
Sims Portex, Inc.
General Hospital · 22d
Cleared Jul 12, 2001
VARISEED 7.0
K012017 · MUJ
Varian Medical Systems
Radiology · 14d
Cleared Jul 12, 2001
VOXAR VC, MODEL 1.0
K012072 · LLZ
Voxar Limited
Radiology · 10d
Cleared Jul 12, 2001
VORTEX
K012097 · LLZ
Ultravisual Medical Systems
Radiology · 7d
Cleared Jul 12, 2001
PROTON THERAPY SYSTEM
K983024 · LHN
Ion Beam Applications S.A.
Radiology · 1046d
Cleared Jul 11, 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · JEY
Macropore Biosurgery, Inc.
Dental · 355d
Cleared Jul 11, 2001
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K003551 · DTN
Jostra AG
Cardiovascular · 236d