Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
144721–144744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1986
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
K861419 · CFJ
Hi Chem, Inc.
Chemistry · 13d
Cleared Apr 28, 1986
QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID
K861448 · JJY
Quantimetrix Medical Industries
Chemistry · 47d
Cleared Apr 25, 1986
DB PRECISION IMPLANT SYSTEM, 2000 SERIES
K860982 · DZE
Driskell Bioengineering
Dental · 39d
Cleared Apr 25, 1986
P.O. VOX
K860993 · ESE
Bloomfield Research and Development,...
Ear, Nose, Throat · 39d
Cleared Apr 25, 1986
GLASIONOMER BASE CEMENT
K861005 · EMA
Shofu Dental Corp.
Dental · 38d
Cleared Apr 25, 1986
TAN MATE HOME TANNING UNIT
K861107 · FTC
Specialty Engineering, Inc.
General & Plastic Surgery · 32d
Cleared Apr 25, 1986
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
K861167 · CZP
Atlantic Antibodies
Immunology · 28d
Cleared Apr 25, 1986
QUIDEL ALLERGY SCREEN
K861171 · DGC
Quidel Corp.
Immunology · 28d
Cleared Apr 25, 1986
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
K861184 · DHB
Pharmacia, Inc.
Immunology · 25d
Cleared Apr 25, 1986
MONITRAL S
K861230 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 24d
Cleared Apr 25, 1986
IAP PLATE TEST
K861336 · LKL
Scientific Sales Intl., Inc.
Immunology · 16d
Cleared Apr 25, 1986
REPLACEMENT HOSES
K861405 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 10d
Cleared Apr 24, 1986
AEROSOL ONE
K852622 · BTI
Ashai Co. , Ltd.
Anesthesiology · 308d
Cleared Apr 24, 1986
EBV(EPSTEIN-BARR VIRUS) TEST KIT
K854207 · GNP
Immuno-Diagnostic Products, Inc.
Microbiology · 190d
Cleared Apr 24, 1986
MMG EXTERNAL FEMALE CATHETERS
K854821 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 142d
Cleared Apr 24, 1986
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
K860087 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 105d
Cleared Apr 24, 1986
BIO-PEN CALCULATOR
K860205 · LQB
Oculab, Inc.
Ophthalmic · 92d
Cleared Apr 24, 1986
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335 · JLX
Diagnostic Products Corp.
Chemistry · 85d
Cleared Apr 24, 1986
SERUM CHOLINESTERASE REAGENT SET
K860350 · DLI
Sterling Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 24, 1986
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
K860713 · CFJ
Catachem, Inc.
Chemistry · 57d
Cleared Apr 24, 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715 · CJE
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
ENZYMATIC BUN REAGENT
K860716 · CDQ
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
K860733 · CGS
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
BETA QUIK STICK
K860965 · JHI
Pacific Biotech, Inc.
Chemistry · 42d