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
174049–174072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1977
MONITOR, HEARTWATCH HEART RATE
K770038 · DRT
Respironics, Inc.
Cardiovascular · 4d
Cleared Jan 14, 1977
SCISSORS, STRABIMUS, 4 STRAIGHT
K770040 · HNF
J. Sklar Mfg. Co., Inc.
Ophthalmic · 4d
Cleared Jan 14, 1977
SCISSORS, STRABISMUS, 4 CURVED
K770041 · HNF
J. Sklar Mfg. Co., Inc.
Ophthalmic · 4d
Cleared Jan 14, 1977
DNC 161 VINCA-FLO
K770043 · KOC
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 141 VINCA-FLO
K770044 · KOC
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 152 VINCA-FLO
K770045 · KOC
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 142 VINCA-FLO
K770046 · KOC
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 151 VINCA-FLO
K770047 · FJT
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 162 VINCA-FLO
K770048 · KOC
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
VITAL-LOK TRACHEAL SWIVEL COUPLING
K770052 · BZA
V.F.P. Corp.
Anesthesiology · 4d
Cleared Jan 14, 1977
COMPOSITE RESTORATIVE MATERIAL, PRESTIGE
K770055 · EBF
Lee Pharmaceuticals
Dental · 3d
Cleared Jan 14, 1977
ORTHOPEDIC SPECIALTIES
K770059
Robert R. Moore
Physical Medicine · 3d
Cleared Jan 14, 1977
VO RESPIRATORY PNEUMOTACHOGRAPH
K770061 · JAX
Research Development Corp.
Anesthesiology · 3d
Cleared Jan 14, 1977
DISP. ABSORBENT COMPRESSED FIBRE WAFER
K770063 · EFN
Lorvic Corp.
Dental · 3d
Cleared Jan 14, 1977
FLUORIDE GEL DISPOSABLE TRAY
K770064 · KMT
Lorvic Corp.
Dental · 3d
Cleared Jan 13, 1977
PROPIOCEPTOR MASSAGER
K760616 · ISA
Cellers Research, Inc.
Physical Medicine · 213d
Cleared Jan 13, 1977
COLON-X
K760777 · FCE
Carlton Hygienics, Inc.
Gastroenterology & Urology · 101d
Cleared Jan 12, 1977
AGGRECETIN
K760893 · JOZ
Bio/Data Corp.
Hematology · 77d
Cleared Jan 12, 1977
MASK ARTIFICIAL RESPIRATION
K760941 · BYG
Gene R. Baldwin
Anesthesiology · 72d
Cleared Jan 12, 1977
PH/BLOOD GAS SYSTEM
K760969 · CHL
Instrumentation Laboratory CO
Chemistry · 69d
Cleared Jan 12, 1977
HEMODIALYSIS CANNULA & FEMORAL CLAMP
K760973 · FIQ
Rodell Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Jan 12, 1977
WEIL ONCOMETER (IL 186)
K760975 · JJK
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Jan 12, 1977
ARTIFICIAL KIDNEY, C-DAK CORDIS DOW
K761007 · FJI
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Jan 12, 1977
REAGENTS
K761086 · JJC
Simmler & Son, Inc.
Chemistry · 58d