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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94489–94512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1997
SUPREME II METER
K963544 · CGA
Chronimed, Inc.
Chemistry · 169d
Cleared Feb 20, 1997
PRECISION G BLOOD GLUCOSE TESTING SYSTEM
K963676 · CGA
Medisense, Inc.
Chemistry · 160d
Cleared Feb 20, 1997
FLEXIBLE CYSTOSCOPE
K964037 · FAJ
Applied Fiberoptics, Inc.
Gastroenterology & Urology · 135d
Cleared Feb 20, 1997
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · LYK
W.L. Gore & Associates, Inc.
Cardiovascular · 133d
Cleared Feb 20, 1997
HEMATACHEK
K964452 · GLK
Richmond Diagnostics, Inc.
Hematology · 106d
Cleared Feb 20, 1997
ACCUPACK PREGNANCY TEST
K964633 · JHI
Genix Biotek, Inc.
Chemistry · 93d
Cleared Feb 20, 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · LPL
Sunsoft Corp.
Ophthalmic · 90d
Cleared Feb 20, 1997
IRON REAGENT
K964913 · JIY
Derma Media Lab., Inc.
Chemistry · 73d
Cleared Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
K964963 · GGN
Bio-Rad
Hematology · 71d
Cleared Feb 20, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH...
K964982 · CEP
Johnson & Johnson Clinical...
Chemistry · 70d
Cleared Feb 20, 1997
THE ADVANCED OSMOMETER (3900)
K965036 · JJM
Advanced Instruments, Inc.
Chemistry · 65d
Cleared Feb 20, 1997
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
K965064 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 64d
Cleared Feb 20, 1997
ACCUMETER H. PYLORI TEST
K965099 · LYR
Chemtrak, Inc.
Microbiology · 62d
Cleared Feb 20, 1997
TUMOR MARKER CONTROL
K965114 · JJY
Diagnostic Products Corp.
Immunology · 62d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · JHI
Abbott Laboratories
Chemistry · 62d
Cleared Feb 20, 1997
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
K970188 · CFT
Sealite Sciences, Inc.
Chemistry · 34d
Cleared Feb 20, 1997
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K970198 · DHN
Scimedx Corp.
Immunology · 30d
Cleared Feb 20, 1997
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
K970396 · JIW
Dade Chemistry Systems, Inc.
Chemistry · 17d
Cleared Feb 19, 1997
COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
K940942 · IYO
Medison America, Inc.
Radiology · 1086d
Cleared Feb 19, 1997
ANTERIOR DYNAMIZED SYSTEM
K953978 · KWQ
Acromed Corp.
Orthopedic · 546d
Cleared Feb 19, 1997
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
K961073 · IYO
Atlantis Diagnostics Intl., Inc.
Radiology · 338d
Cleared Feb 19, 1997
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH...
K962702 · GCJ
General Surgical Innovations
General & Plastic Surgery · 222d
Cleared Feb 19, 1997
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
K964305 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 113d
Cleared Feb 19, 1997
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K964665 · DSY
Carbomedics, Inc.
Cardiovascular · 90d