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

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176,076 results
69721–69744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2004
ZYOPTIX XP MICROKERATOME
K040204 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Mar 22, 2004
INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS
K040205 · NHA
Intra-Lock International
Dental · 52d
Cleared Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
K040541 · JAQ
Varian Medical Systems, Inc.
Radiology · 20d
Cleared Mar 22, 2004
SOMATOM PROJECT P30L
K040577 · JAK
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Mar 22, 2004
MESACUP TEST MPO, MODEL 11053
K040586 · MOB
Rhigene, Inc.
Immunology · 17d
Cleared Mar 22, 2004
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
K040640 · MOS
Igc-Medical Advances, Inc.
Radiology · 12d
Cleared Mar 19, 2004
ACCULASER PRO4
K023060 · NHN
Acculaser, Inc.
Physical Medicine · 553d
Cleared Mar 19, 2004
SOLAR GI SYSTEM
K031084 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 350d
Cleared Mar 19, 2004
KRYO ART CONTROLLED RATE FREEZER
K032086 · MQG
Planer Plc
Obstetrics & Gynecology · 256d
Cleared Mar 19, 2004
CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
K032863 · GEX
Biolitec, Inc.
General & Plastic Surgery · 189d
Cleared Mar 19, 2004
CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
K032864 · GEX
Biolitec, Inc.
General & Plastic Surgery · 189d
Cleared Mar 19, 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389 · LJS
C.R. Bard, Inc.
General Hospital · 148d
Cleared Mar 19, 2004
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · HQD
Contamac, Ltd.
Ophthalmic · 127d
Cleared Mar 19, 2004
SHAPE LOCKING ENDOSCOPIC OVERTUBE
K033954 · FED
Usgi Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 19, 2004
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
K033998 · DQA
Masimo Corp.
Anesthesiology · 86d
Cleared Mar 19, 2004
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
K034024 · EBI
Bisco, Inc.
Dental · 81d
Cleared Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Mar 19, 2004
PEDIATRIC AORTIC ROOT CANNULA
K040173 · DWF
Medtronic Perfusion Systems
Cardiovascular · 53d
Cleared Mar 19, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K040229 · DXN
A&D Engineering, Inc.
Cardiovascular · 46d
Cleared Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · JPA
Instrumentation Laboratory CO
Hematology · 35d
Cleared Mar 19, 2004
KERATO ANALYZER (EKA)
K040373 · NQE
Konan Medical, Inc.
Ophthalmic · 31d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Mar 19, 2004
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
K040547 · DYH
Harry J. Bosworth Co.
Dental · 17d
Cleared Mar 19, 2004
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K040548 · DYH
Harry J. Bosworth Co.
Dental · 17d