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
172153–172176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1977
ELECTROSURGICAL GENERATOR
K771639 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 95d
Cleared Nov 29, 1977
IRRIGATING NEEDLE, ILLUMINATED
K771785
Concept, Inc.
General & Plastic Surgery · 67d
Cleared Nov 29, 1977
CATHETER, VEIN, FEMORAL, SF 10
K772146 · FJT
Sorensen Research
Hematology · 15d
Cleared Nov 29, 1977
CATHETER, FEMORAL VEIN, SF 6
K772148 · FJT
Sorensen Research
Hematology · 15d
Cleared Nov 28, 1977
LIGACLIP MULTIPLE CLIP APPLIER
K771412 · GDO
Ethicon, Inc.
General & Plastic Surgery · 119d
Cleared Nov 28, 1977
LIGACLIP MULTIPLE LIGATING CLIPS
K771413 · FZP
Ethicon, Inc.
General & Plastic Surgery · 119d
Cleared Nov 28, 1977
BETA-CAP
K771420 · FJS
Quinton, Inc.
Gastroenterology & Urology · 119d
Cleared Nov 28, 1977
CATHETER FINGER GRIP
K771483 · FJS
Quinton, Inc.
Gastroenterology & Urology · 116d
Cleared Nov 28, 1977
PERITONEAL DIALYSIS CATHETER
K771555 · FJS
Fluoro-Mold Co.
Gastroenterology & Urology · 108d
Cleared Nov 28, 1977
ARMOR-KOT SURGICAL INSTRUMENTS
K771680 · FSM
Storz Instrument Co.
General & Plastic Surgery · 83d
Cleared Nov 28, 1977
HEMATOLOGY REFERENCE CONTROL
K771753 · JPK
Coulter Electronics, Inc.
Hematology · 73d
Cleared Nov 28, 1977
SPECTROPHOTOMETER ANALYSIS SYS.
K771807 · JJQ
Varian Assoc., Inc.
Chemistry · 63d
Cleared Nov 28, 1977
CATHETER, CEBTRAL VENOUS, 2N1501
K771861 · JCY
Travenol Laboratories, S.A.
General & Plastic Surgery · 56d
Cleared Nov 28, 1977
DAYSTAR SURG. LIGHT 9100 & ORBITER 9110
K771865 · FSY
Castle Co.
General & Plastic Surgery · 56d
Cleared Nov 28, 1977
HEARTBEATER
K771924 · DXG
Dunn Instruments, Inc.
Cardiovascular · 46d
Cleared Nov 28, 1977
ACUTE CARDIAC CARE SYSTEM
K772006 · DRT
Physio-Control Corp.
Cardiovascular · 38d
Cleared Nov 28, 1977
CARDIAC PACEMAKER S6001
K772009 · DXY
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 28, 1977
CARDIAC PACEMAKER C2001
K772010 · DXY
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 28, 1977
TRANSDUCER PROTECTOR
K772040 · FKJ
Terumo America, Inc.
Hematology · 31d
Cleared Nov 28, 1977
ALPHA/CHOL
K772043 · CGO
Standard Scientific, Inc.
Hematology · 31d
Cleared Nov 28, 1977
CRITICAL CARE VENTILATOR 2
K772065 · CBK
Ohio Medical Products
Anesthesiology · 26d
Cleared Nov 28, 1977
ENZAC URIC ACID 100-TEST KIT
K772082 · CDH
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared Nov 28, 1977
PACING LEAD MODEL 6991A
K772104 · DTB
Medtronic Vascular
Cardiovascular · 21d
Cleared Nov 28, 1977
CREATININE URINE APPLI.-#32308
K772107 · CGX
Harleco
Chemistry · 21d