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
151297–151320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1984
CARDI-CK EIA TEST KIT CK-MB ISOENZYME
K843007 · JHS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 07, 1984
EVER-BOND V GLASS LONOMER RESTORATIVE
K843072 · EBF
Kerr Corporation (Danbury)
Dental · 32d
Cleared Sep 07, 1984
APCO FISSURE SEALER & BONDING AGENT
K843098 · EBC
Scientific Pharmaceuticals, Inc.
Dental · 31d
Cleared Sep 07, 1984
ALBUMIN ASSAY KIT
K843104 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 07, 1984
STERILE SOLUTION BOWL
K843115 · KDD
E.M. Adams
Neurology · 30d
Cleared Sep 07, 1984
GUIDE TO THE KNEE
K843121 · BWN
Dyonics, Inc.
General & Plastic Surgery · 30d
Cleared Sep 07, 1984
MOBILE OPERATING TABLE HEIDELBERGS 1130
K843134 · GDC
Stierlen-Maquet AG
General & Plastic Surgery · 29d
Cleared Sep 07, 1984
K-BASS LO FREQUENCY HEARING AID
K843144 · ESD
Etymotic Research
Ear, Nose, Throat · 28d
Cleared Sep 07, 1984
AUGMENTIN 30 MCG SENSITIVITY DISKS
K843172 · JTN
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Sep 07, 1984
TOTAL BILIRUBIN TEST
K843178 · CIG
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 07, 1984
CREATININE TEST
K843179 · CGX
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 07, 1984
SALICYLATE TEST
K843180 · DKJ
Sclavo, Inc.
Toxicology · 25d
Cleared Sep 07, 1984
T-TYPE IV EXTENSION SET
K843249 · FPA
Strato Medical Corp.
General Hospital · 18d
Cleared Sep 07, 1984
SYSTEMATE CK-TOTAL - 67206
K843271 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 07, 1984
DIFFERENTIATION DISKS BILE ESCULIN
K843364 · JSF
Difco Laboratories, Inc.
Microbiology · 10d
Cleared Sep 07, 1984
MOLINEA UNDERPADS
K843402 · KME
Paul Hartmann Corp.
General Hospital · 8d
Cleared Sep 07, 1984
TOP HYPODERMIC SYRINGE PISTON
K843414 · FMF
Top Surgical Manufacturers Co.
General Hospital · 7d
Cleared Sep 06, 1984
MONITORING KIT
K833171 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 356d
Cleared Sep 06, 1984
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · JBQ
Instrumentation Laboratory CO
Hematology · 132d
Cleared Sep 06, 1984
C-PEP-RIA-100
K842267 · JKD
Institut National Des Radioelements
Chemistry · 90d
Cleared Sep 06, 1984
HEMATOLOGY ANALYZER
K842310 · JKL
Hml Inc/Biotechnology Transfer
Hematology · 86d
Cleared Sep 06, 1984
DILU-MATIC 140
K842446 · GKH
Abbott Diagnostics
Hematology · 77d
Cleared Sep 06, 1984
CELL-MATICS VIRAL TRANSPORT PACK
K843173 · JTW
Difco Laboratories, Inc.
Microbiology · 24d
Cleared Sep 06, 1984
BHK-21
K843250 · KIR
Viromed Laboratories, Inc.
Pathology · 17d