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
108457–108480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1994
DIAGNOSTIC ULTRASOUND SYSTEM
K915403 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 881d
Cleared May 03, 1994
MISCELLANEOUS PACING LEAD
K925168 · DTD
Oscor Medical Corp.
Cardiovascular · 567d
Cleared May 03, 1994
THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
K930842 · HQE
Grieshaber & Co.
Ophthalmic · 440d
Cleared May 03, 1994
AME(R) UNIVERSIAL CABLE SYSTEM
K932687 · JDQ
American Medical Electronics, Inc.
Orthopedic · 334d
Cleared May 03, 1994
TECNOL PCM 2000
K932834 · FXX
Tecnol Medical Products, Inc.
General Hospital · 327d
Cleared May 03, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
K932923 · LPH
Implex Corp.
Orthopedic · 322d
Cleared May 03, 1994
FOUNDATION ALL POLY CUP
K934169 · JDI
Encore Orthopedics, Inc.
Orthopedic · 249d
Cleared May 03, 1994
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K935404 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 175d
Cleared May 03, 1994
MEDNEXT BUR
K935861 · HBE
Mednext, Inc.
Neurology · 151d
Cleared May 03, 1994
PS MEDICAL CATHETER PLACEMENT KIT
K940096 · GWG
Pudenz-Schulte Medical Research Corp.
Neurology · 116d
Cleared May 03, 1994
COMPLETELY IN THE CANAL
K940116 · ESD
Argosy Electronics
Ear, Nose, Throat · 113d
Cleared May 03, 1994
METHAQUALONE ENZYME IMMUNOASSAY
K940123 · KXS
Diagnostic Reagents, Inc.
Toxicology · 113d
Cleared May 03, 1994
QUANTITATIVE HEART
K940236 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared May 03, 1994
MITOCHONDRIA EIA TEST KIT
K940251 · DBM
David A. Fuccillo, Ph.D.
Immunology · 104d
Cleared May 03, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · KXT
Schiapparelli Biosystems, Inc.
Chemistry · 102d
Cleared May 03, 1994
IMPACT
K940390 · JQW
Matrix Technologies Corp.
Chemistry · 97d
Cleared May 03, 1994
ACS POWERBASE(TM) CORONARY GUIDING CATHETER
K940559 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared May 03, 1994
CLINIX VP 4 TABLE
K940721 · IXR
Philips Medical Systems (Cleveland),...
Radiology · 74d
Cleared May 03, 1994
ADJUSTABLE BALLOON DISSECTION CANNULA
K940875 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 67d
Cleared May 03, 1994
LIFE VAC
K940934 · BTA
Life Support Products, Inc.
General & Plastic Surgery · 68d
Cleared May 03, 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · JFJ
Synermed, Inc.
Chemistry · 56d
Cleared May 03, 1994
LIQUID ALT(SGPT) REAGENT SET
K941287 · CKA
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared May 03, 1994
PENT CORE PLUS (PASTE-PASTE)
K941373 · EBF
Jeneric/Pentron, Inc.
Dental · 42d
Cleared May 03, 1994
CONQUEST SMOOTH TOUCH
K941377 · EBF
Jeneric/Pentron, Inc.
Dental · 42d