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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117721–117744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1992
TECHNA SUN LENS
K915661 · HQY
Techna Intl.
Ophthalmic · 91d
Cleared Mar 18, 1992
MICROAIRE MODEL 2600
K915670 · GEF
Microaire
General & Plastic Surgery · 90d
Cleared Mar 18, 1992
MODIFIED DISPOSABLE FETAL VACUUM
K915763 · HDB
Columbia Medical & Surgical, Inc.
Obstetrics & Gynecology · 85d
Cleared Mar 18, 1992
DMA LD KINETIC PROCEDURE
K915803 · CFJ
Data Medical Associates, Inc.
Chemistry · 85d
Cleared Mar 18, 1992
OPUS FERRITIN TEST SYSTEM
K915838 · DGE
Pb Diagnostic Systems, Inc.
Immunology · 85d
Cleared Mar 18, 1992
ENDOSCOPIC TRANSLUMINATOR
K915854 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 82d
Cleared Mar 18, 1992
SURESEAL ENDOSCOPIC VALVE
K920030 · ODC
Applied Urology, Inc.
Gastroenterology & Urology · 75d
Cleared Mar 18, 1992
DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
K920034 · JWH
Pfizer Hospital Products Group, Inc.
Orthopedic · 72d
Cleared Mar 18, 1992
ENCORE SCL-70
K920150 · LKJ
Clark Laboratories, Inc.
Immunology · 65d
Cleared Mar 18, 1992
USCI HEMAQUET XT INTRODUCER
K920251 · DYB
C.R. Bard, Inc.
Cardiovascular · 57d
Cleared Mar 18, 1992
DIRECTIGEN NEISSERIA MENINGITIDIS TEST
K920274 · GTI
Bd Becton Dickinson Vacutainer...
Microbiology · 56d
Cleared Mar 18, 1992
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
K920345 · CFT
Medix Biotech, Inc.
Chemistry · 51d
Cleared Mar 18, 1992
IMMUCHEM TSH-MW ELISA
K920442 · JLW
Icn Biomedicals, Inc.
Chemistry · 44d
Cleared Mar 18, 1992
DRUG OF ABUSE URINE CONTROL
K920477 · DIF
Diagnostic Reagents, Inc.
Toxicology · 50d
Cleared Mar 18, 1992
THE LEWIS TUBE HOLDER
K920691 · CBH
R. Lewis, Inc.
Anesthesiology · 33d
Cleared Mar 18, 1992
THC URINE CALIBRATORS
K920749 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Mar 18, 1992
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
K920900 · BTR
Polamedco, Inc.
Anesthesiology · 21d
Cleared Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
K920935 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Mar 18, 1992
PHENCYCLIDINE EIA ASSAY, MODIFICATION
K920957 · LCM
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Mar 17, 1992
CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE
K914167 · CKE
Eastman Kodak Company
Chemistry · 182d
Cleared Mar 17, 1992
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3
K914204 · JJY
Medical Analysis Systems, Inc.
Chemistry · 180d
Cleared Mar 17, 1992
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · LJM
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Mar 17, 1992
MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER
K915366 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 111d
Cleared Mar 17, 1992
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508 · JZG
Diagnostic Systems Laboratories, Inc.
Immunology · 99d