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
153241–153264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1984
ANA APPLELISA
K834241 · DHN
Apple Diagnostic Products
Immunology · 120d
Cleared Apr 04, 1984
PALL HEAT MOISTURE EXCHANGING FILTER
K834292 · BYD
Pall Biomedical Products Co.
Anesthesiology · 118d
Cleared Apr 04, 1984
OLSEN 756 ROCKER SWITCHPEN
K834329 · GEI
Olsen Electro-Surgical Instruments, Inc.
General & Plastic Surgery · 114d
Cleared Apr 04, 1984
DOUBLE-COAGULATION SWITCHPEN 757
K834410 · GEI
Olsen Electro-Surgical Instruments, Inc.
General & Plastic Surgery · 111d
Cleared Apr 04, 1984
MAST INHALANT PROFILE
K834526 · DHB
Mast Immunosystems
Immunology · 105d
Cleared Apr 04, 1984
DETECT GROUP A STREP TEST
K834582 · GTZ
Difco Laboratories, Inc.
Microbiology · 97d
Cleared Apr 04, 1984
PROGRESS SELECTIVE DHEMISTRY ANALYZ
K840200 · JJF
Kone Instruments, Inc.
Chemistry · 76d
Cleared Apr 04, 1984
PARATHYROID HORMONE ANALYSIS PRODUCT
K840379 · CEW
Nichols Institute Diagnostics
Chemistry · 68d
Cleared Apr 04, 1984
VENTREZYME T4 IMMUNOASSAY T4
K840473 · KLI
Vxr, Inc.
Chemistry · 61d
Cleared Apr 04, 1984
ACCULAB SUPPLIES CHEMICAL ANALYZERS
K840501 · JJE
Precision Technology, Inc.
Chemistry · 58d
Cleared Apr 04, 1984
CATS-CLINICAL LAB COMPUTER SOFTWARE-
K840502 · JQP
Precision Technology, Inc.
Chemistry · 58d
Cleared Apr 04, 1984
HAEMOPHILUS INFLUENZAE TYPE B
K840506 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 58d
Cleared Apr 04, 1984
REAGENTS & STANDARDS IL 501 NA/K
K840557 · JGS
Shaban Mfg. Co.
Chemistry · 56d
Cleared Apr 04, 1984
AMERLEX HUMAN PLACENTAL LACTOGEN
K840588 · JMF
Amersham Corp.
Chemistry · 55d
Cleared Apr 04, 1984
QUINIDINE ANALYTICAL TEST PACK
K840596 · LBZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 04, 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840606 · CIG
Eastman Kodak Company
Chemistry · 54d
Cleared Apr 04, 1984
LIQUI-URA CHEMISTRY URINE CONTROLS
K840618 · JJW
Biodiagnostic Intl
Chemistry · 50d
Cleared Apr 04, 1984
B-NEOCEPT 30
K840650 · JHJ
Organon, Inc.
Chemistry · 49d
Cleared Apr 04, 1984
ENTERNAL Y EXTENSION SET RECORDER
K840656 · KNT
Corpak Medsystems
Gastroenterology & Urology · 49d
Cleared Apr 04, 1984
PARAMAX ACID PHOSPHATASE REAGENT
K840661 · CKB
American Dade
Hematology · 49d
Cleared Apr 04, 1984
SENSIBEAD EIA IGE KIT
K840674 · DGC
Terumo Medical Corp.
Immunology · 49d
Cleared Apr 04, 1984
PDC HDL EZ-SEP CHOLESTEROL REAGENT
K840676 · LBS
Preventive Diagnostics Corp.
Chemistry · 49d
Cleared Apr 04, 1984
ASPARTATE AMINOTRANSFERASE REAGENT
K840706 · CIT
American Dade
Hematology · 47d
Cleared Apr 04, 1984
BAKTERIETTE-VI-PAK
K840719 · JTW
Great Lakes Intl.
Microbiology · 47d