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
152905–152928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1984
QTA PROCESSOR MODULE
K840138 · IYO
General Electric Co.
Radiology · 104d
Cleared Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 103d
Cleared Apr 25, 1984
SINGLE LUMEN SUBCLAVIAN CANNULA
K840197 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 25, 1984
PRESSURE SENTRY TOURNIQUET
K840206 · KCY
Richards Medical Co., Inc.
General & Plastic Surgery · 97d
Cleared Apr 25, 1984
DIAMOND LUSTRE
K840254 · EJR
Jelrus Technical Products Corp.
Dental · 93d
Cleared Apr 25, 1984
SILICONE SUCTION & IRRIGATION DRAIN
K840323 · GBX
Superior Plastic Products Corp.
General & Plastic Surgery · 91d
Cleared Apr 25, 1984
SILICONE SUMP DRAIN 20 & 40 FRENCH
K840324 · JCY
Superior Plastic Products Corp.
General & Plastic Surgery · 91d
Cleared Apr 25, 1984
LINEAR ARRAY TRANSDUCER OR SCANHEAD
K840408 · IYO
Adr Ultrasound
Radiology · 85d
Cleared Apr 25, 1984
REPLACE-A-TIP HIGH TEMP. CAUTERY
K840433 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 84d
Cleared Apr 25, 1984
REPLACE-A-TIP LOW TEMP. CAUTERY
K840434 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 84d
Cleared Apr 25, 1984
TOTAL BILIRUBIN REAGENT
K840486 · CIG
Somas Medical Industries, Inc.
Chemistry · 79d
Cleared Apr 25, 1984
SHUTT PRECISION PROBES
K840558 · HXB
Concept, Inc.
Orthopedic · 77d
Cleared Apr 25, 1984
DENTAL HANDPIECE
K840690 · EFB
Pen-Med Technology, Inc.
Dental · 69d
Cleared Apr 25, 1984
PERIO PIK
K840721 · EFS
Teledyne, Inc.
Dental · 68d
Cleared Apr 25, 1984
DIA-H 1/2/3 & DIA-HT 1/2/3
K840801
Diatech, Inc.
Hematology · 62d
Cleared Apr 25, 1984
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817 · KPJ
Hospitak, Inc.
General & Plastic Surgery · 61d
Cleared Apr 25, 1984
SECURLINE SURGICAL SKIN MARKER 1000
K840820 · FZZ
Precision Dynamics Corp.
General & Plastic Surgery · 61d
Cleared Apr 25, 1984
MODULAR CONSTRUCT FRAME EXTERNAL FIXA
K840856 · JEC
Precision Medical Devices, Inc.
Orthopedic · 61d
Cleared Apr 25, 1984
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID
K840873 · EIH
Shofu Dental Corp.
Dental · 58d
Cleared Apr 25, 1984
PHASE II FREE T4 KIT
K840901 · CEC
Medical & Scientific Designs, Inc.
Chemistry · 57d
Cleared Apr 25, 1984
SUN BEDS
K840931 · FTC
Wakewood Sunbeds
General & Plastic Surgery · 54d
Cleared Apr 25, 1984
TOGGLE LOCKING PLIER
K840978 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 50d
Cleared Apr 25, 1984
SLIP JOINT PLIER
K840979 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 50d
Cleared Apr 25, 1984
HALF ROUND FILE
K840980 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 50d