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
69265–69288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2004
ENVOY PATIENT MONITOR
K024245 · OMC
Mennen Medical , Ltd.
Neurology · 504d
Cleared May 10, 2004
COMPRESSION ANASTOMOSIS CLIP (CAC)
K033324 · FZP
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 208d
Cleared May 10, 2004
CEMEX GENTA BONE CEMENT
K033596 · LOD
Exactech, Inc.
Orthopedic · 178d
Cleared May 10, 2004
COLLAGEN WOUND DRESSING - ORAL
K040403 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 83d
Cleared May 10, 2004
RANDOX METHADONE ASSAY
K040570 · DJR
Randox Laboratories, Ltd.
Toxicology · 67d
Cleared May 10, 2004
SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K040602 · FZP
Design Standards Corp.
General & Plastic Surgery · 63d
Cleared May 10, 2004
ENDOTINE TRANSBLEPH DEVICE
K040740 · HWC
Coapt Systems, Inc.
Orthopedic · 49d
Cleared May 10, 2004
MODIFICATION TO ADPER PROMPT
K040857 · KLE
3M Espe AG Dental Products
Dental · 38d
Cleared May 10, 2004
QUANTEX FERRITIN
K040879 · DBF
Instrumentation Laboratory CO
Immunology · 35d
Cleared May 10, 2004
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · JFJ
Teco Diagnostics
Chemistry · 32d
Cleared May 10, 2004
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K041032 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 19d
Cleared May 10, 2004
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
K041135 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 10d
Cleared May 07, 2004
OMNI~NEB
K030396 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 456d
Cleared May 07, 2004
G-FREEZEKIT BLAST
K032154 · MQL
Vitrolife AB
Obstetrics & Gynecology · 298d
Cleared May 07, 2004
G-THAWKIT BLAST
K032155 · MQL
Vitrolife AB
Obstetrics & Gynecology · 298d
Cleared May 07, 2004
LAFACI
K032400 · FYD
Vision Pro, LLC
General Hospital · 277d
Cleared May 07, 2004
G-OOCYTE
K032877 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 235d
Cleared May 07, 2004
OSTEO ACL SCREW MODEL
K032894 · HWC
Linvatec Biomaterials, Inc.
Orthopedic · 233d
Cleared May 07, 2004
FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
K032927 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 228d
Cleared May 07, 2004
G-PGD
K033101 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 221d
Cleared May 07, 2004
APAPORE BONE GRAFT SUBSTITUTE
K033722 · MQV
Apatech , Ltd.
Orthopedic · 163d
Cleared May 07, 2004
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789 · LZC
Cardinalhealth
General Hospital · 155d
Cleared May 07, 2004
IVC SYSTEM
K040317 · ILO
Mark H. Friedman
Physical Medicine · 88d
Cleared May 07, 2004
BIOFILL BONE VOID FILLER
K040454 · MQV
Scient'X
Orthopedic · 74d