FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77497–77520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT....
K013102 · JMO
Wiener Laboratories Saic
Chemistry · 57d
Cleared Nov 13, 2001
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
K013133 · MOQ
Nordix, Inc.
General & Plastic Surgery · 55d
Cleared Nov 13, 2001
SCANTAC MEMBRANE OR SCANTAC STRIP
K013170 · ITX
Sonotech, Inc.
Radiology · 50d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 13, 2001
AUTOJECT 2
K013362 · KZH
Owen Mumford USA, Inc.
General Hospital · 34d
Cleared Nov 13, 2001
MODEL MES-9000/EMG SYSTEM
K013399 · HCC
Myotronics-Noromed, Inc.
Neurology · 29d
Cleared Nov 13, 2001
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL...
K013603 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
K013604 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
K013633 · IYO
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 09, 2001
VT-1
K012619 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
SE-200
K012620 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
REPROCESSED LINVATEC ARTHROSCOPIC BURS
K012630 · HRX
Alliance Medical, Inc.
Orthopedic · 88d
Cleared Nov 09, 2001
SE-300 VACUUM THERAPY SYSTEM
K012639 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
TONOPORT V
K012647 · DXN
Par Medizintechnik GmbH
Cardiovascular · 88d
Cleared Nov 09, 2001
SE-100 VACUUM ERECTION DEVICE
K012662 · LKY
Vts, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012664 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 88d
Cleared Nov 09, 2001
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012665 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 88d
Cleared Nov 09, 2001
BOSS 2000-3 VACUUM ERECTION DEVICE
K012670 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
BOSS-2000-2 VACUUM ERECTION DEVICE
K012672 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
VANGUARD REPROCESSED PHACOEMULSIFICATION
K012698 · NKX
Vanguard Medical Concepts, Inc.
Ophthalmic · 87d
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES...
K012824 · DIS
ACON Laboratories, Inc.
Toxicology · 78d
Cleared Nov 09, 2001
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
K012951 · FGB
Circon Video
Gastroenterology & Urology · 66d
Cleared Nov 09, 2001
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
K012962 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 66d
Cleared Nov 09, 2001
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
K012964 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 66d