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
72913–72936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2002
FLEXIMA BILIARY CATHETER
K023870 · FGE
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 30d
Cleared Dec 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · MEB
I-Flow Corp.
General Hospital · 29d
Cleared Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Dec 20, 2002
MODIFICATION TO MEDIPRIME
K023936 · LLZ
Algotec Systems, Ltd.
Radiology · 24d
Cleared Dec 20, 2002
VOYAGER LINUX
K023975 · HAW
Z-Kat, Inc.
Neurology · 18d
Cleared Dec 20, 2002
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · FDT
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 14d
Cleared Dec 20, 2002
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K024036 · IPF
Johari Digital Healthcare , Ltd.
Physical Medicine · 14d
Cleared Dec 20, 2002
TILITE EVO
K024055 · IOR
Tisport, LLC
Physical Medicine · 11d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · HWC
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING,...
K024106 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 7d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING,...
K024121 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 4d
Cleared Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
K014215 · FGE
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 363d
Cleared Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
K021637 · KGN
Acell, Inc.
General & Plastic Surgery · 216d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 19, 2002
TRANSITIONAL IMPLANTS
K021915 · DZE
Intra-Lock International
Dental · 191d
Cleared Dec 19, 2002
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
K022660 · DRR
Biocheck, Inc.
Chemistry · 132d
Cleared Dec 19, 2002
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · GAM
Ethicon, Inc.
General & Plastic Surgery · 126d
Cleared Dec 19, 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
K023137 · LLZ
Philips Medical Systems North America...
Radiology · 90d
Cleared Dec 19, 2002
ECHO SOUNDER, ES-102EX
K023143 · KNG
Koven Technology, Inc.
Radiology · 90d
Cleared Dec 19, 2002
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
K023264 · FRN
Alaris Medical Systems, Inc.
General Hospital · 80d
Cleared Dec 19, 2002
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K023280 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 79d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · GAQ
Aesculap, Inc.
General & Plastic Surgery · 69d
Cleared Dec 19, 2002
BIOPSY SITE TISSUE MARKER DEVICE
K023450 · NEU
Promex, Inc.
General & Plastic Surgery · 65d
Cleared Dec 19, 2002
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE...
K023669 · JJY
Medical Analysis Systems, Inc.
Chemistry · 49d