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
147553–147576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1985
SCANLAN TUNNELER, SHEATH & TIP
K851825 · DWS
Scanlan Intl., Inc.
Cardiovascular · 77d
Cleared Jul 12, 1985
CHLORIDE ASSAY KIT
K852058 · CHJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 64d
Cleared Jul 12, 1985
OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18
K852374 · CAN
The Timeter Group
Anesthesiology · 38d
Cleared Jul 12, 1985
HYBRITECH IMMUNOCHEMISTRY ANALYZER
K852385 · JJF
Hybritech, Inc.
Chemistry · 37d
Cleared Jul 12, 1985
MDCK
K852394 · KIR
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
MINK LUNG
K852395 · KIR
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
HEK
K852396 · KIR
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
VISUAL SERUM/URINE HCG COMBO KIT
K852437 · JHI
American Bioclinical, Inc.
Chemistry · 32d
Cleared Jul 12, 1985
NML TSH IRMA
K852438 · JLW
Nuclear Medical Laboratories, Inc.
Chemistry · 32d
Cleared Jul 12, 1985
CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET
K852461 · JIT
Medical Analysis Systems, Inc.
Chemistry · 32d
Cleared Jul 12, 1985
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · JGS
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jul 12, 1985
CELLGRO WILLIAMS' MEDIUM E
K852475 · KIT
Mediatech, Inc.
Pathology · 31d
Cleared Jul 12, 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
K852483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jul 12, 1985
CELLGRO(ISCOVE'S MEDIUM) MODIFICATION
K852485 · KIT
Mediatech, Inc.
Pathology · 31d
Cleared Jul 12, 1985
BIOGLAS MICROCARRIER BEAD
K852506 · KJB
Solohill Engineering, Inc.
Pathology · 30d
Cleared Jul 12, 1985
TECHNICON CHEMI
K852565 · CGX
Technicon Instruments Corp.
Chemistry · 35d
Cleared Jul 12, 1985
MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON
K852568 · KIT
Sigma Chemical Co.
Pathology · 24d
Cleared Jul 12, 1985
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
K852573 · KLS
Technicon Instruments Corp.
Toxicology · 24d
Cleared Jul 12, 1985
CLED AGAR
K852578 · JSH
American Laboratory Supply, Inc.
Microbiology · 24d
Cleared Jul 12, 1985
GONI-KIT
K852582 · JSX
Culture Kits, Inc.
Immunology · 24d
Cleared Jul 12, 1985
DATA CHEM IRON PROCEDURE
K852583 · CFM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Jul 12, 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 12, 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 12, 1985
MCCOY'S 5A MEDIUM-LIQUID FORM
K852602 · KIT
Mediatech, Inc.
Pathology · 23d