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
162769–162792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1981
MODEL 84 TRANSPORT SYSTEM
K811372 · DSP
Datascope Corp.
Cardiovascular · 80d
Cleared Aug 03, 1981
NICHOLAS II, VIRAL-BACTERIAL FILTER
K811546 · CAH
K & G Healthcare Ind., Inc.
General Hospital · 63d
Cleared Aug 03, 1981
ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR
K811758 · DXH
Powers Medical Systmes
Cardiovascular · 42d
Cleared Aug 03, 1981
MODEL D BIPOLAR ENDOCARDIAL LEAD
K811876 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL C UNIPOLAR ENDOCARDIAL LEAD
K811877 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL B BIPOLAR ENDOCARDIAL LEAD
K811878 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL A UNIPOLAR ENDOCARDIAL LEAD
K811879 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
FLU VEN I.V. SETS
K811914 · FPA
Venusa , Ltd.
General Hospital · 33d
Cleared Aug 03, 1981
OREIA II, B-HCG
K811940 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Aug 03, 1981
RADIOIMMUNOASSAY, FOLLICLE STIMULATING
K811993 · CGJ
Endocrine-Metabolic Center
Chemistry · 20d
Cleared Aug 03, 1981
PEDIATRIC DOUBLE SWIVEL CONNECTOR
K812000 · BZA
Mallinckrodt Critical Care
Anesthesiology · 20d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027 · CIW
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028 · CEK
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
K812029 · CDT
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030 · CIX
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KALLESTAD ANTISERA TO GENTAMICIN
K812050 · DJI
Kallestad Laboratories, Inc.
Toxicology · 13d
Cleared Aug 03, 1981
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN
K812066 · BYF
Airlife, Inc.
Anesthesiology · 13d
Cleared Aug 03, 1981
AEGIS I.V. STRIPS
K812080 · KMK
Warner-Lambert Co.
General Hospital · 12d
Cleared Jul 31, 1981
LUMAC'S BACTERIURIA SCREENING KIT
K810746 · JXA
Lumac
Toxicology · 134d
Cleared Jul 31, 1981
D-3160 SORBENT CARTRIDGE
K811170 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 94d
Cleared Jul 31, 1981
OPHTHALMIC SCISSORS
K811245 · HNF
Keeler Instruments, Inc.
Ophthalmic · 88d
Cleared Jul 31, 1981
HEMASITE VASCULAR ACCESS SHUNT
K811384 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 73d
Cleared Jul 31, 1981
OECO APNEA MONITOR
K811628 · BZQ
Oeco
Anesthesiology · 52d
Cleared Jul 31, 1981
SOFT & STROKE
K811782 · ISA
Phoenix Intl. Marketing, Inc.
Physical Medicine · 38d