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
149833–149856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · FRN
Pacesetter Systems
General Hospital · 43d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K844851 · FRN
Pacesetter Systems
General Hospital · 40d
Cleared Jan 22, 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898 · HKI
Canon USA, Inc.
Ophthalmic · 36d
Cleared Jan 22, 1985
HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
K850070 · DXN
Healthcheck Corp.
Cardiovascular · 18d
Cleared Jan 18, 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · GQL
Syva Co.
Microbiology · 303d
Cleared Jan 18, 1985
BIOMATT-1
K841392 · BZQ
Biorec Us, Inc.
Anesthesiology · 290d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR/ATRIAL
K842031 · DTB
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
MODELS 4012/4512 TRANSVENOUS TINED-
K842032 · DTB
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
EPICARDIAL, UNIPOLAR LEAD 4951
K842065 · DTD
Medtronic Vascular
Cardiovascular · 241d
Cleared Jan 18, 1985
4A
K842122 · CBK
Life Products, Inc.
Anesthesiology · 234d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR LEAD
K842145 · DTD
Medtronic Vascular
Cardiovascular · 233d
Cleared Jan 18, 1985
PATIENT MONITOR 78354A
K842236 · DRT
Hewlett-Packard Co.
Cardiovascular · 227d
Cleared Jan 18, 1985
MODEL 503FB
K842759 · LOS
Atrix
Cardiovascular · 186d
Cleared Jan 18, 1985
ESKA MULTISTAGE ESOPHAGEAL BOUGIE
K843186 · FAT
Dacomed Corp.
Gastroenterology & Urology · 158d
Cleared Jan 18, 1985
MODULAR FIBERSCOPE SYSTEM
K843683 · GCP
Reichert Scientific Instruments
Gastroenterology & Urology · 122d
Cleared Jan 18, 1985
STERILE SALINE SOLUTION
K843797 · BSY
Paco Pharmaceutical Services, Inc.
Anesthesiology · 113d
Cleared Jan 18, 1985
SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
K844051 · NXA
Washington-Greene County Branch...
Anesthesiology · 93d
Cleared Jan 18, 1985
FORCEPS & HAMOSTATS
K844062 · GEN
I M, Inc.
General & Plastic Surgery · 92d
Cleared Jan 18, 1985
COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
K844066 · CGJ
Clinetics Corp.
Chemistry · 92d
Cleared Jan 18, 1985
CARDIOPAC DEFIBRILLATOR 444
K844103 · LDD
Birtcher Corp.
Cardiovascular · 87d
Cleared Jan 18, 1985
LP-5
K844179 · CBK
Life Products, Inc.
Anesthesiology · 84d
Cleared Jan 18, 1985
GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR
K844216 · JXE
Grass Instrument Co.
Neurology · 79d
Cleared Jan 18, 1985
UNITED SKIN BARRIER PASTE
K844341 · EZR
Howmedica Corp.
Gastroenterology & Urology · 71d
Cleared Jan 18, 1985
SARTORIUS MINISART SM 16596HY
K844504 · KOC
Sartorius Filters, Inc.
Gastroenterology & Urology · 59d