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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76993–77016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 09, 2001
BCS SYSTEM
K013114 · JPA
Dade Behring, Inc.
Hematology · 52d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126 · JIS
Dade Behring, Inc.
Chemistry · 51d
Cleared Nov 09, 2001
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
K013152 · LBS
Elan Holdings, Inc.
Chemistry · 50d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · LCX
Unipath , Ltd.
Chemistry · 29d
Cleared Nov 09, 2001
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
K013393 · KFM
A-Med Systems, Inc.
Cardiovascular · 25d
Cleared Nov 09, 2001
FAS SET #4551
K013497 · MQE
Gynetics Medical Products NV
Obstetrics & Gynecology · 18d
Cleared Nov 09, 2001
STANDARD IMAGING IVB 1000 WELL CHAMBER
K013548 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Nov 09, 2001
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
K013573 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 11d
Cleared Nov 08, 2001
3CC NMT SAFETY SYRINGE
K010819 · MEG
New Medical Technology , Ltd.
General Hospital · 234d