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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
141913–141936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 1986
FASCICULATED S ROD
K863271
The Deca Co.
Orthopedic · 121d
Cleared Dec 24, 1986
MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN
K864184 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 58d
Cleared Dec 24, 1986
MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN
K864185 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 58d
Cleared Dec 24, 1986
HIGH FREQUENCY NEEDLE-TYPE EPILATOR
K864291 · KCW
Multi-Channel Epilator
General & Plastic Surgery · 54d
Cleared Dec 24, 1986
CARETEX SHOE COVERS
K864550 · FXP
James River Corp.
General Hospital · 35d
Cleared Dec 24, 1986
AKRO-SIL PLUS
K864736 · KOD
Akron Catheter, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 24, 1986
THE KEYMED HI-LIGHT 250 LIGHT SOURCE
K864801 · GCT
Keymed, Inc.
Gastroenterology & Urology · 15d
Cleared Dec 24, 1986
CLOWARD DISPOSABLE ARMRESTS AND FACE REST
K864804
Surgical Equipment International, Inc.
General & Plastic Surgery · 15d
Cleared Dec 24, 1986
CLOWARD SURGICAL SADDLE
K864805
Surgical Equipment International, Inc.
General & Plastic Surgery · 15d
Cleared Dec 24, 1986
INFECTIOUS TISSUE KIT
K864824
American Scientific Products
General & Plastic Surgery · 15d
Cleared Dec 24, 1986
RADIOGRAPHIC - LEG SECTION
K864846 · KQS
American Sterilizer Co.
Gastroenterology & Urology · 14d
Cleared Dec 24, 1986
2000LT WHEELCHAIR
K864901 · IOR
Invacare Corp.
Physical Medicine · 9d
Cleared Dec 24, 1986
HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
K864918 · INO
Health Products, Inc.
Physical Medicine · 8d
Cleared Dec 23, 1986
BIOPSY ADAPTER #H4221BG
K864551 · GDF
General Electric Co.
General & Plastic Surgery · 34d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC
K864780 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC
K864782 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC
K864783 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 22, 1986
NBP 488, TPR 488
K861856 · DXN
Siemens Medical Solutions USA, Inc.
Cardiovascular · 222d
Cleared Dec 22, 1986
AXION IV GOLDLINE SERIES
K862602 · GZJ
Ventura Medical Electronics
Neurology · 167d
Cleared Dec 22, 1986
HEALTHPHONE(TM)
K862668 · DXH
Carelink
Cardiovascular · 161d
Cleared Dec 22, 1986
NELLCOR MVP, MODEL N-1000
K862812 · DQA
Nellcor, Inc.
Anesthesiology · 151d
Cleared Dec 22, 1986
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
K862837 · HSX
Osteonics Corp.
Orthopedic · 150d
Cleared Dec 22, 1986
M700 STRESS MONITOR
K863466 · DRT
Kone Instruments, Inc.
Cardiovascular · 105d
Cleared Dec 22, 1986
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · DRT
Advantage Medical Systems, Inc.
Cardiovascular · 104d