FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
128377–128400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1990
ARTHRODISTRACTOR
K896770 · HRX
Arthroplastics, Inc.
Orthopedic · 33d
Cleared Jan 02, 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860 · KLT
Pb Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Jan 02, 1990
OPUS PHENYTOIN TEST SYSTEM
K896868 · LGR
Pb Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Jan 02, 1990
CHIROPRACTIC MASSAGE PILLOW
K896947 · IRO
Intl. Pacific Industrial Corp. (Usa),...
Physical Medicine · 20d
Cleared Jan 02, 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025 · DHN
Zeus Scientific, Inc.
Immunology · 14d
Cleared Jan 02, 1990
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · KSA
R&D Systems, Inc.
Hematology · 15d
Cleared Dec 29, 1989
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
K890349 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 339d
Cleared Dec 29, 1989
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
K891986 · KME
Mark One Healthcare Products
General Hospital · 276d
Cleared Dec 29, 1989
MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
K894608 · GWF
Micro-Shev , Ltd.
Neurology · 164d
Cleared Dec 29, 1989
SQA
K894949 · POV
United Medical Systems, Inc.
Hematology · 148d
Cleared Dec 29, 1989
MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
K895864 · LXS
Lasag AG
Ophthalmic · 87d
Cleared Dec 29, 1989
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
K895917 · GKZ
Coulter Immunology
Hematology · 80d
Cleared Dec 29, 1989
EVOLUTION HIP SYSTEM
K896105 · KWL
Dow Corning Wright
Orthopedic · 70d
Cleared Dec 29, 1989
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 46d
Cleared Dec 29, 1989
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · CFL
Medix Biotech, Inc.
Chemistry · 35d
Cleared Dec 29, 1989
TINY HALOGEN EXAM LIGHT
K896962 · KZF
Jedmed Instrument Co.
General Hospital · 14d
Cleared Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · DQO
Bd Becton Dickinson Vacutainer...
Cardiovascular · 373d
Cleared Dec 28, 1989
GRASPING FORCEPS
K896058 · KOA
Annex Medical, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 27, 1989
LATEX EXAMINATION GLOVES
K893461 · LYY
Zhum Heng Development , Ltd.
General Hospital · 238d
Cleared Dec 27, 1989
ACC.U.DIAL
K894423 · JJQ
Exocell, Inc.
Chemistry · 163d
Cleared Dec 27, 1989
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · GAA
E-Z-Em, Inc.
General & Plastic Surgery · 141d
Cleared Dec 27, 1989
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139 · LBS
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared Dec 27, 1989
CHEMO-SPIKE RECONSTITUTION DEVICE
K895290 · FPA
The Medi-Dose Group
General Hospital · 124d
Cleared Dec 27, 1989
IV DISPESNSING SPIKE
K895291 · FPA
The Medi-Dose Group
General Hospital · 124d