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
156649–156672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1983
ARIA II I-HCG
K830997 · JHI
Bd Becton Dickinson Vacutainer...
Immunology · 65d
Cleared Jun 02, 1983
MILLER-ABBOTT TUBE
K830998 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
CANTOR TUBE
K831009 · KNT
Medovations, Inc.
Gastroenterology & Urology · 64d
Cleared Jun 02, 1983
DUOCLON SLIDE TEST
K831109 · JHI
Organon, Inc.
Immunology · 58d
Cleared Jun 02, 1983
B-CLONE HCG ASSAY
K831155 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 55d
Cleared Jun 02, 1983
ARUBI FLATTER & ARUBI FLATTER-S
K831206 · ISA
Kc Export Management Co.
Physical Medicine · 50d
Cleared Jun 02, 1983
RIAGEN B-HCG RIA KIT
K831221 · JHI
Biogenex Laboratories
Chemistry · 48d
Cleared Jun 02, 1983
BETA-QUIK-15 RIA KIT
K831223 · JHI
Pacific Biotech, Inc.
Chemistry · 48d
Cleared Jun 02, 1983
COMPUR EASY TOUCH CHEMISTRY ANALYZER-
K831227 · JJF
Worthington Diagnostic Systems
Chemistry · 48d
Cleared Jun 02, 1983
GLENOID RESURFACE COMPONENT PMN 3M
K831234 · KWT
3M Company
Orthopedic · 48d
Cleared Jun 02, 1983
BIPOLAR CARD
K831236 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 48d
Cleared Jun 02, 1983
QST TM SAMPLE PROCESSOR
K831273 · JQW
Syva Co.
Chemistry · 44d
Cleared Jun 02, 1983
ELECTROSURGICAL UNIT-MF 380 #60-1700
K831291 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 43d
Cleared Jun 02, 1983
EVEN-TEMP. CAPACITIVE ADHESIVE PAD
K831299 · GEI
Delta Medical Electronics, Inc.
General & Plastic Surgery · 42d
Cleared Jun 02, 1983
EMIT QST GENTAMICIN ASSAY
K831304 · LCD
Syva Co.
Immunology · 42d
Cleared Jun 02, 1983
NUTROMAT
K831325 · GBB
Medlog GmbH Marketing Services
General & Plastic Surgery · 38d
Cleared Jun 02, 1983
ALLERCOAT ALLERGEN DISCS
K831326 · DGC
Kallestad Laboratories, Inc.
Immunology · 38d
Cleared Jun 02, 1983
API UNISCEPT PLUS AUTOINOCULATOR
K831341 · JTC
Analytical Products, Inc.
Immunology · 38d
Cleared Jun 02, 1983
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE
K831342 · CDZ
Diagnostic Products Corp.
Chemistry · 38d
Cleared Jun 02, 1983
MICROCAPILLARY INFUSION SYSTEM
K831347 · FFX
J.S. Biomedicals, Inc.
Gastroenterology & Urology · 38d
Cleared Jun 02, 1983
EMIT QST QUINIDINE ASSAY
K831355 · LBZ
Syva Co.
Toxicology · 37d
Cleared Jun 02, 1983
BOUNDARY HEADWEAR
K831357 · FYF
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 37d
Cleared Jun 02, 1983
BETA-PREG
K831361 · JHJ
Catheter Technology Corp.
Microbiology · 37d
Cleared Jun 02, 1983
TESTCORP ANA
K831365 · LKS
Catheter Technology Corp.
Microbiology · 37d