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
142873–142896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1986
GLUCOSE HK PROCEDURE
K863259 · CFR
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
DEMAND TOTAL PROTEIN
K863301 · CEK
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
K863328 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
K863329 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 26, 1986
FORMALENS 2000
K863367 · HQG
Vision-Sciences, Inc.
Ophthalmic · 23d
Cleared Sep 26, 1986
DERMATEC BURN PADS
K863379 · NAD
Dermatec, Inc.
General & Plastic Surgery · 23d
Cleared Sep 26, 1986
DELFIA(TM) CORTISOL KIT
K863422 · JFT
Lkb Instruments, Inc.
Chemistry · 22d
Cleared Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 26, 1986
RAICHEM(TM) CHLORIDE REAGENT
K863620 · CHJ
Reagents Applications, Inc.
Chemistry · 10d
Cleared Sep 26, 1986
QUANTIMAP III
K863650 · OLT
Quantified Signal Imaging, Inc.
Neurology · 8d
Cleared Sep 26, 1986
LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50
K863706 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 3d
Cleared Sep 26, 1986
LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40
K863707 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 3d
Cleared Sep 25, 1986
RSL (125I) ALDOSTERONE KIT
K862204 · CJM
Radioassay Systems Laboratories, Inc.
Chemistry · 107d
Cleared Sep 25, 1986
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
K862336 · CGR
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 97d
Cleared Sep 25, 1986
FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
K862444 · HHR
Laser Media
Obstetrics & Gynecology · 91d
Cleared Sep 25, 1986
EXEL THREE-WAY STOPCOCK
K862492 · FMG
Exel Intl.
General Hospital · 86d
Cleared Sep 25, 1986
RABINOWITZ GUM MASSAGER
K862635 · JEW
Arnell, Inc.
Dental · 77d
Cleared Sep 25, 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · ELW
Dentsply Intl.
Dental · 57d
Cleared Sep 25, 1986
THE BIO-TEK UW-II
K862932 · IMJ
Bio-Tek Instruments, Inc.
Physical Medicine · 52d
Cleared Sep 25, 1986
CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES
K862952 · HPX
Paco Pharmaceutical Services, Inc.
Ophthalmic · 51d
Cleared Sep 25, 1986
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
K862955 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 51d
Cleared Sep 25, 1986
MERIVAARA PATIENT TROLLEY - MODEL #416
K862959 · FPO
Global Medical Prods, Inc.
General Hospital · 51d
Cleared Sep 25, 1986
FREE T3 RADIOIMMUNOASSAY KIT
K862968 · KHQ
Bioclinical Group
Chemistry · 50d
Cleared Sep 25, 1986
GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX
K863009 · EJP
Sds Dental, Inc.
Dental · 48d