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
55369–55392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2008
SOMATOM FLASH DS
K082220 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Oct 10, 2008
CD HORIZON SPINAL SYSTEM
K082236 · NKB
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Oct 10, 2008
AURAGEN CORTICAL SURFACE ELECTRODES
K082250 · GYC
Integra Neurosciences
Neurology · 63d
Cleared Oct 10, 2008
NUVASIVE SPHERX SYSTEM
K082332 · NKB
Nuvasive, Inc.
Orthopedic · 57d
Cleared Oct 10, 2008
PAX-500
K082350 · OAS
VATECH Co., Ltd.
Radiology · 56d
Cleared Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
K082653 · JAQ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 10, 2008
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
K082675 · JPA
Diagnostica Stago, Inc.
Hematology · 25d
Cleared Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680 · JIT
Siemens Healthcare Diagnostics
Chemistry · 25d
Cleared Oct 10, 2008
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
K082702 · PHX
Exactech, Inc.
Orthopedic · 24d
Cleared Oct 10, 2008
TEMPUSIC PATIENT MONITOR
K082718 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 23d
Cleared Oct 10, 2008
INFX-8000H, INFINIX-I
K082830 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 10, 2008
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
K082959 · DSA
Unimed Medical Supplies, Inc.
Cardiovascular · 7d
Cleared Oct 09, 2008
VIDAS CEA (S) ASSAY
K080194 · DHX
bioMerieux, Inc.
Immunology · 258d
Cleared Oct 09, 2008
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K080275 · OMP
Iasis Medical, Inc.
General & Plastic Surgery · 251d
Cleared Oct 09, 2008
UNISCAN -DOA SYSTEM
K080347 · DJC
Taiwan Unison Biotech, Inc.
Toxicology · 244d
Cleared Oct 09, 2008
OXISCAN II DATA MANAGEMENT SYSTEM
K080348 · DQA
Airsep Corp.
Anesthesiology · 241d
Cleared Oct 09, 2008
DIO SM IMPLANT SYSTEM
K080559 · DZE
Dsi, Inc.
Dental · 224d
Cleared Oct 09, 2008
PIVOT ASSIST
K081053 · INO
Pivot Assist, LLC
Physical Medicine · 178d
Cleared Oct 09, 2008
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT...
K081178 · HQD
Contamac, Ltd.
Ophthalmic · 167d
Cleared Oct 09, 2008
MODIFICATION TO MIRAGE MICRO
K081321 · BZD
Resmed, Ltd.
Anesthesiology · 150d
Cleared Oct 09, 2008
URESTA PESSARY
K081385 · HHW
Eastmed, Inc.
Obstetrics & Gynecology · 146d
Cleared Oct 09, 2008
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
K081670 · CBK
Cardinal Health 207, Inc.
Anesthesiology · 118d
Cleared Oct 09, 2008
PERFADEX WITH THAM
K081997 · MSB
Vitrolife Sweden AB
Gastroenterology & Urology · 87d
Cleared Oct 09, 2008
PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
K082237 · BZD
Mallinckrodt Developpement France
Anesthesiology · 63d