FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157345–157368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 17, 1983
RIGHT TIME RHYTHM CLOCK
K823463 · LHD
P.K. Morgan Instruments, Inc.
Obstetrics & Gynecology · 118d
Cleared Mar 17, 1983
AMP 80/2 OUTFLOW MONITOR MODIFICATION
K823827 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 17, 1983
THERACARD 400
K823828 · LDD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 87d
Cleared Mar 17, 1983
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 85d
Cleared Mar 17, 1983
T-TUBE VENT TUBE
K823909 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 17, 1983
IMPROVED ARTHROSCOPE
K830120 · HRX
Markoptic
Orthopedic · 65d