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
158185–158208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1983
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · DFT
Isolab, Inc.
Chemistry · 27d
Cleared Mar 24, 1983
USCI GRUNTZIG DILACA BALLOON DILATION
K830608 · LIT
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Mar 24, 1983
INFLATION DEVICE
K830609 · DXT
Interventional Medical, Inc.
Cardiovascular · 27d
Cleared Mar 24, 1983
RA SCREENING TEST
K830611 · DHR
Tago, Inc.
Immunology · 24d
Cleared Mar 24, 1983
CYTO-STAIN
K830625 · HJQ
Richard-Allan Medical Ind., Inc.
Pathology · 23d
Cleared Mar 24, 1983
CLARIFIER-RICHARD-ALLAN
K830627 · KEM
Richard-Allan Medical Ind., Inc.
Pathology · 23d
Cleared Mar 24, 1983
VERTEX DIGITAL SUBSTRATION KIT
K830637 · DQO
Professional Medical Services
Cardiovascular · 23d
Cleared Mar 24, 1983
ANTI N DNA-HCP
K830652 · KTL
Immuno-Products Industries
Immunology · 17d
Cleared Mar 24, 1983
INFUSION PUMP RETROGRADE EXTEN. AS 715
K830654 · FPA
Narco Scientific
General Hospital · 23d
Cleared Mar 24, 1983
ORAL SPONGE
K830675 · GEO
Unisplint Corp.
General & Plastic Surgery · 21d
Cleared Mar 24, 1983
DIGITIZING COLORIZING APPLE COMPUTER SYSTEM FOR RE-VIEW OF NORMAL ROENTGEN FILM
K837100
Dr. John D. Reid B.A., D.C.
Radiology · 51d
Cleared Mar 23, 1983
TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM
K837142
Hoffrel Instruments, Inc.
Radiology · 79d
Cleared Mar 22, 1983
ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE
K837029
American Electromedics Corp.
Radiology · 102d
Cleared Mar 22, 1983
2D CARDIAC SECTOR SCANNER
K837097
Second Foundation, Inc.
Radiology · 55d
Cleared Mar 22, 1983
ELDER PSORALITE SERIES 2000 UVA IRRADIATION SYSTEM
K837106
Elder Pharmaceuticals, Inc.
Radiology · 71d
Cleared Mar 22, 1983
ULTRAVIOLET ELDER PSORALITE SERIES 3000 UVA
K837108
Elder Pharmaceuticals, Inc.
Radiology · 71d
Cleared Mar 22, 1983
UNKNOWN
K837109
Elder Pharmaceuticals, Inc.
Radiology · 68d
Cleared Mar 22, 1983
BLUE GREEN FILTER SYSTEM TO MODEL 152 AND 150 LASER SYSTEM
K837151
Britt Corp., Inc.
Radiology · 57d
Cleared Mar 22, 1983
THERAC 25 LINEAR ACCELERATOR
K837152 · JAI
Atomic Energy of Canada
Radiology · 387d
Cleared Mar 22, 1983
STANDEX SYSTEM
K837178
Elscint, Inc.
Radiology · 34d
Cleared Mar 21, 1983
RAICHEM HDL-CHOLESTEROL REAGENT
K830207 · LBR
Reagents Applications, Inc.
Chemistry · 59d
Cleared Mar 17, 1983
ORTHO RUBELLA ELISA TEST SYSTEM
K822342 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 225d
Cleared Mar 17, 1983
DOSIMETRY RELEASE OF RADIATION STERIL.
K823059
Biomet, Inc.
Orthopedic · 150d
Cleared Mar 17, 1983
MENISCECTOMY TRAY #9715
K823424 · HAW
Concept, Inc.
Neurology · 121d