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
95401–95424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1996
CONTACT LENS WITH COLOR ADDITIVE
K962911 · LPL
Cal Bionics
Ophthalmic · 128d
Cleared Nov 29, 1996
OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
K962952 · LBK
Olympus Optical, Co.
Neurology · 122d
Cleared Nov 29, 1996
LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC...
K963011 · LPL
Permeable Technologies, Inc.
Ophthalmic · 119d
Cleared Nov 29, 1996
GIARDIA CELISA
K963135 · MHI
Techlab, Inc.
Microbiology · 109d
Cleared Nov 29, 1996
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
K963693 · CEP
Princeton BioMeditech Corp.
Toxicology · 74d
Cleared Nov 29, 1996
GAUZE SPONGE, NON X-RAY DETECTABLE
K963724 · EFQ
Grand Medical Products
General & Plastic Surgery · 74d
Cleared Nov 29, 1996
NASP TRANSPARENT DRESSING
K963753 · MGP
North American Sterilization &...
General & Plastic Surgery · 72d
Cleared Nov 29, 1996
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K963763 · JGS
Medica Corp.
Chemistry · 71d
Cleared Nov 29, 1996
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · GIS
Ortho Diagnostic Systems, Inc.
Hematology · 63d
Cleared Nov 29, 1996
AVL COMPACT 3 PH/BLOOD GAS ANALYZER
K963964 · CHL
Avl Scientific Corp.
Chemistry · 58d
Cleared Nov 29, 1996
CAPILLARY ADAPTOR ACCESSORY
K963992 · CGZ
Medica Corp.
Toxicology · 56d
Cleared Nov 29, 1996
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE...
K964269 · HIL
Playtime Products, Inc.
Obstetrics & Gynecology · 35d
Cleared Nov 29, 1996
WATERS 515 HPLC PUMP (515)
K964588 · KIE
Waters Corporation
Toxicology · 14d
Cleared Nov 27, 1996
KONSTRUCT PATELLAR COMPONENT
K960856 · JWH
Biomet, Inc.
Orthopedic · 271d
Cleared Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K962061 · LNH
GE Medical Systems
Radiology · 183d
Cleared Nov 27, 1996
GALILEO ENDOSCOPES
K962116 · EOB
Galileo Electro-Optics Corp.
Ear, Nose, Throat · 180d
Cleared Nov 27, 1996
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
K962195 · IRT
Sunbeam Health Division
Physical Medicine · 173d
Cleared Nov 27, 1996
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
K962217 · MKZ
Gen-Probe, Inc.
Microbiology · 170d
Cleared Nov 27, 1996
QUASAR RECOVERY IMAGING PACKAGE
K962481 · KPS
Trionix Research Laboratory, Inc.
Radiology · 154d
Cleared Nov 27, 1996
INCARE HOT/ICE LITE MACHINE
K962537 · ILO
Hollister, Inc.
Physical Medicine · 152d
Cleared Nov 27, 1996
BIOMID BONE MARROW BIOPSY NEEDLE
K962569 · FCG
Gallini Intl., Inc.
Gastroenterology & Urology · 149d
Cleared Nov 27, 1996
ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
K962570 · FCG
Gallini Intl., Inc.
Gastroenterology & Urology · 149d
Cleared Nov 27, 1996
ISOLA PEDIATRIC COMPONENTS
K962984 · KWP
Acromed Corp.
Orthopedic · 118d
Cleared Nov 27, 1996
GLOVEL GX
K963020 · KGO
Kenwell International , Ltd.
General Hospital · 114d