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
167953–167976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1979
MEDTRONIC BURR HOLE PLUG & CAP
K792206
Medtronic Vascular
Neurology · 23d
Cleared Nov 21, 1979
ELECTROCARDIOGRAPH, MODEL ECG-5151
K792229 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 16d
Cleared Nov 21, 1979
MEDTRONIC MODEL 9408 TELETRACE TRANSMIT
K792246 · DXH
Medtronic Vascular
Cardiovascular · 14d
Cleared Nov 21, 1979
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
K792283 · DRR
Arzbaecher & Co.
Cardiovascular · 8d
Cleared Nov 21, 1979
MEDTRONIC MODEL 7728 NEUROMOD
K792311 · GZJ
Medtronic Vascular
Neurology · 5d
Cleared Nov 21, 1979
HEART RATE MONITOR MD-1
K792312 · DRT
Medical Devices, Inc.
Cardiovascular · 5d
Cleared Nov 20, 1979
VISALENS CONCENTRATED CLEANER CONT LENS
K791524 · HPX
Pfizer, Inc.
Ophthalmic · 102d
Cleared Nov 20, 1979
HYDROGEL-PREP
K791726 · NAB
Spenco Medical Corp.
General & Plastic Surgery · 77d
Cleared Nov 20, 1979
ORALUMINATOR III AUTO-LIGHT
K791771 · EAY
Midwest
Dental · 74d
Cleared Nov 20, 1979
HOWMEDICA A-35 DENTAL ALLOY
K791973 · EJS
Howmedica Corp.
Dental · 49d
Cleared Nov 20, 1979
HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY
K792008 · EJS
Howmedica Corp.
Dental · 46d
Cleared Nov 20, 1979
I.V. STRIP
K792049 · KMK
E-Med Corp.
General Hospital · 39d
Cleared Nov 20, 1979
FOLLICLE STIMULATING HORMONE (FSH) KIT
K792063 · CGJ
Cis Radiopharmaceuticals, Inc.
Immunology · 36d
Cleared Nov 20, 1979
POROUS ELASTIC RUBBER BANDAGE
K792065 · FQM
Norman R. Sanborn Co.
General Hospital · 36d
Cleared Nov 20, 1979
HISTO-CENTER II
K792095 · IDW
Thermolyne Corp.
Pathology · 34d
Cleared Nov 20, 1979
COUITER/CMS ISOTONIC BLOOD BANK SALINE
K792101 · JCE
Coulter Electronics, Inc.
Hematology · 32d
Cleared Nov 20, 1979
VITA-STAT MODEL 900-D
K792193 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 19d
Cleared Nov 20, 1979
VITA-STAT MODEL 900-S
K792194 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 19d
Cleared Nov 20, 1979
TROCAR CATHETER/THORACIC CATHETER
K792202 · DWF
Portex, Inc.
Cardiovascular · 18d
Cleared Nov 20, 1979
GDC 802-DEVELOPMENT NAME
K792210 · EJT
Deringer-Ney, Inc.
Dental · 18d
Cleared Nov 16, 1979
LIO-714 OPACITYMETER
K790526 · HJL
Laser Industries , Ltd.
Ophthalmic · 246d
Cleared Nov 16, 1979
ADR-10600(ADR 400),10601 (ADR 300)
K791342 · FKX
Physio-Control Corp.
Gastroenterology & Urology · 122d
Cleared Nov 16, 1979
CYLER/HEATER FOR PERITONEAL DIALYSIS
K791584 · KPF
American Medical Products, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 16, 1979
CLOSED SYSTEM FOLEY CATHERIZATION PROCED
K791598 · KOD
Walpak Co.
Gastroenterology & Urology · 91d