Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78121–78144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 08, 2001
IQUANTIFY, VERSION 1.0
K011196 · LLZ
Insightful Corporation
Radiology · 203d
Cleared Nov 08, 2001
UNI-GOLD STREP A TEST KIT
K011709 · GTZ
Trinity Biotech, Plc
Microbiology · 157d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Cook, Inc.
Neurology · 150d
Cleared Nov 08, 2001
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
K011994 · MGQ
Acrymed, Inc.
General & Plastic Surgery · 135d
Cleared Nov 08, 2001
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
K012326 · JGJ
Wiener Laboratories Saic
Chemistry · 108d
Cleared Nov 08, 2001
REPROCESSED PHACO TIPS
K012579 · NKX
Sterilmed, Inc.
Ophthalmic · 91d
Cleared Nov 08, 2001
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE,...
K012624 · HRX
Medical Instruments Technology, Inc.
Orthopedic · 87d