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
158137–158160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1982
HARRIS HEMATOXYLIN
K823328 · HYK
Accra Laboratories, Inc.
Pathology · 50d
Cleared Dec 28, 1982
PAPINCOLABU STAIN EA-36/50/65 & OG-6
K823329 · HZL
Accra Laboratories, Inc.
Pathology · 50d
Cleared Dec 28, 1982
HEMATOLOGY ANALYZER
K823344 · GKL
Abbott Diagnostics
Hematology · 50d
Cleared Dec 28, 1982
H. INFLUENZA B ANTISERA FOR CIE
K823348 · GRP
Diagnostica, Inc.
Immunology · 49d
Cleared Dec 28, 1982
COULTER-COUNTER #S PLUS IV & LYSE S +D
K823355 · GKZ
Coulter Electronics, Inc.
Hematology · 49d
Cleared Dec 28, 1982
DADE ESR KIT
K823368 · JPH
American Dade
Hematology · 48d
Cleared Dec 28, 1982
PEDIATRIC URINE COLLECTOR
K823411 · KNX
Sage Products, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 28, 1982
ALKPHOR SYSTEM
K823445 · CIN
California Immuno Diagnostic, Inc.
Chemistry · 42d
Cleared Dec 28, 1982
FEMALE EXTERNAL URINARY APPLIANCE
K823450 · KNX
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 41d
Cleared Dec 28, 1982
SINGLE VIAL AMYLASE PNP TEST
K823462 · JFJ
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Dec 28, 1982
ULTRA CHEM BAN-UV #65080 & 65081
K823472 · CDQ
Emd Chemicals, Inc.
Chemistry · 36d
Cleared Dec 28, 1982
GAMMADAB LH RADIO-KIT #CA-1508
K823476 · CEP
Clinical Assays, Inc.
Chemistry · 36d
Cleared Dec 28, 1982
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · GBX
Travenol Laboratories, S.A.
General & Plastic Surgery · 35d
Cleared Dec 28, 1982
PARA 12
K823498 · GLQ
Streck Laboratories, Inc.
Hematology · 34d
Cleared Dec 28, 1982
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507 · DGC
Hybritech, Inc.
Chemistry · 34d
Cleared Dec 28, 1982
CURAY ANTERIOR/POSTERIOR RESTORATIVE
K823510 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 29d
Cleared Dec 28, 1982
FIBROSYSTEM
K823520 · GKQ
Bd Becton Dickinson Vacutainer...
Hematology · 29d
Cleared Dec 28, 1982
DILULAB 230
K823522 · GKH
Innovative Medical Systems, Inc.
Hematology · 29d
Cleared Dec 28, 1982
OXYGEN CONCENTRATOR
K823524 · CAW
C.R. Bard, Inc.
Anesthesiology · 29d
Cleared Dec 28, 1982
INTRALIG
K823536 · EJI
Miltex Instrument Co.
Dental · 28d
Cleared Dec 28, 1982
COMPRESSION HIP SCREW SIDE-PLATE
K823548 · KTT
Howmedica Corp.
Orthopedic · 28d
Cleared Dec 28, 1982
REMOVAWELL PLATE LID
K823557 · LIB
Dynatech Corp.
Chemistry · 26d
Cleared Dec 28, 1982
CORNING 170 PH/BLOOD GAS ANALYZER
K823570 · CHL
Corning Medical & Scientific
Chemistry · 25d
Cleared Dec 28, 1982
AMEDA HAND BREAST PUMP
K823591 · HGY
Burditt & Calkins-Siemens-Elema
Obstetrics & Gynecology · 22d