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
67081–67104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2004
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP...
K041125 · IWB
Masep Med Science & Tech. Development...
Radiology · 244d
Cleared Dec 30, 2004
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K042221 · LLZ
Barco NV Barcoview
Radiology · 135d
Cleared Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
K043230 · LON
bioMerieux, Inc.
Microbiology · 38d
Cleared Dec 29, 2004
PEDIGUARD NERVE DETECTOR SYSTEM
K030526 · GWF
Spine Vision, Inc.
Neurology · 679d
Cleared Dec 29, 2004
TITANIUM MESH IMPLANT
K041407 · MQP
Interpore Cross Intl.
Orthopedic · 216d
Cleared Dec 29, 2004
ACUPUNCTURE NEEDLES
K041652 · MQX
C.A.I. Industries Corp.
General Hospital · 195d
Cleared Dec 29, 2004
VISIOPLAST ACRYLIC RESIN
K042414 · GXP
Tecres
Neurology · 113d
Cleared Dec 29, 2004
DISPOSABLE NON-ADHESIVE SPO2 SENSORS
K042705 · DQA
Elekon Industries U.S.A., Inc.
Anesthesiology · 90d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
K042713 · MQP
Spine Next America Corporation
Orthopedic · 90d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
K042714 · MQP
Spine Next America Corporation
Orthopedic · 96d
Cleared Dec 29, 2004
WATCH PAT 100S
K042916 · MNR
Itamar Medical
Anesthesiology · 69d
Cleared Dec 29, 2004
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
K042975 · DIS
Ameditech, Inc.
Toxicology · 62d
Cleared Dec 29, 2004
DIFOTI USB 2.0 SYSTEM
K043068 · NTK
Electro-Optical Sciences, Inc.
Dental · 51d
Cleared Dec 29, 2004
PMP4 OXY PRO
K043162 · DQA
Card Guard Scientific Survival , Ltd.
Anesthesiology · 43d
Cleared Dec 29, 2004
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T...
K043167 · JXM
Phamatech, Inc.
Chemistry · 43d
Cleared Dec 29, 2004
ONLINE DAT BARBITURATES PLUS
K043211 · DIS
Roche Diagnostics Corp.
Toxicology · 40d
Cleared Dec 29, 2004
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
K043378 · JIT
Drew Scientific , Ltd.
Chemistry · 21d
Cleared Dec 29, 2004
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
K043397 · FMI
Becton, Dickinson & CO
General Hospital · 19d
Cleared Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481 · FGE
Cook, Inc.
Gastroenterology & Urology · 14d
Cleared Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · MQP
Medtronic Sofamor Danek
Orthopedic · 2d
Cleared Dec 28, 2004
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
K042381 · DQY
Acumen Medical, Inc.
Cardiovascular · 118d
Cleared Dec 28, 2004
CAPSULE TENSION RING INSERTER, MODEL 7-810
K042478 · NCE
Duckworth & Kent, Ltd.
Ophthalmic · 106d
Cleared Dec 28, 2004
SPACEVISION CAGE SYSTEM
K042930 · MQP
Spine Vision, Inc.
Orthopedic · 67d
Cleared Dec 28, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · MNH
Medtronic Sofamor Danek
Orthopedic · 22d