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
87673–87696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1998
BIO-2000
K973765 · EIA
Micrylium Laboratories
Dental · 398d
Cleared Nov 04, 1998
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556 · MQB
Canon USA, Inc.
Radiology · 187d
Cleared Nov 04, 1998
SPIFE URINE IFE
K982639 · DAO
Helena Laboratories
Immunology · 98d
Cleared Nov 04, 1998
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
K982760 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Nov 04, 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790 · LYR
Inova Diagnostics, Inc.
Microbiology · 86d
Cleared Nov 04, 1998
AUTO-LYTE PCP EIA, MODEL #1254U
K982801 · LCM
OraSure Technologies, Inc.
Toxicology · 86d
Cleared Nov 04, 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · FRN
Sims Deltec, Inc.
General Hospital · 84d
Cleared Nov 04, 1998
DIGIRAD 2020TC SPECT IMAGING SYSTEM
K982855 · KPS
Digirad Corp.
Radiology · 90d
Cleared Nov 04, 1998
HELAX-IMCON, VERSION 1.0
K982857 · KPQ
Helax AB
Radiology · 83d
Cleared Nov 04, 1998
SILHOUETTE VR
K982955 · KPR
GE Medical Systems
Radiology · 72d
Cleared Nov 04, 1998
QUANTA LITE RF IGG ELISA
K983083 · DHR
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
QUANTA LITE RF IGA ELISA
K983084 · DHR
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Nov 04, 1998
IGM
K983132 · DFT
Abbott Laboratories
Immunology · 57d
Cleared Nov 04, 1998
CT BIOPSYVIEW
K983140 · JAK
Philips Medical Systems North...
Radiology · 57d
Cleared Nov 04, 1998
TRF
K983167 · DDG
Abbott Laboratories
Immunology · 55d
Cleared Nov 04, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209 · DKB
Beckman Coulter, Inc.
Toxicology · 51d
Cleared Nov 04, 1998
IGG
K983221 · DEW
Abbott Laboratories
Immunology · 51d
Cleared Nov 04, 1998
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
K983285 · EIA
Engle Dental Systems
Dental · 47d
Cleared Nov 04, 1998
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K983304 · CIG
Synermed Intl., Inc.
Chemistry · 44d
Cleared Nov 04, 1998
C4
K983356 · DBI
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
IGA
K983359 · CZP
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
C3
K983441 · CZW
Abbott Laboratories
Immunology · 35d
Cleared Nov 04, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
K983507 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · JIT
Dade Behring, Inc.
Chemistry · 14d