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
118537–118560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1992
SENOGRAPHE DMR/SMR/DM
K913418 · IZH
General Electric Co.
Radiology · 159d
Cleared Jan 06, 1992
KODAK X-OMAT 480 RA PROCESSOR
K914143 · IXW
Eastman Kodak Company
Radiology · 112d
Cleared Jan 06, 1992
NSN #6545-00-656-1093 KIT, FIRST AID
K914478 · LYY
Cooperative Workshops, Inc.
General Hospital · 90d
Cleared Jan 06, 1992
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
K914484 · HLI
Hgm Medical Laser Systems, Inc.
Ophthalmic · 90d
Cleared Jan 06, 1992
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914514 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 89d
Cleared Jan 06, 1992
HEART TECHNOLOGY WIRECLIP
K914581 · DQX
Heart Technology, Inc.
Cardiovascular · 82d
Cleared Jan 06, 1992
DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)
K914910 · GEI
Davol, Inc.
General & Plastic Surgery · 66d
Cleared Jan 06, 1992
I-125 SEEDS CODE: 6702
K915156 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 53d
Cleared Jan 06, 1992
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
K915163 · GGP
Biopool AB
Hematology · 53d
Cleared Jan 03, 1992
ESPE KETAC-ENDO APLICAP
K911061 · EMA
H.A. Opotow Consulting
Dental · 298d
Cleared Jan 03, 1992
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667 · JBQ
The Binding Site, Ltd.
Hematology · 137d
Cleared Jan 03, 1992
HEMO-PULSE 2000
K914142 · IRP
Chrono Dynamics, Ltd.
Physical Medicine · 109d
Cleared Jan 03, 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Jan 03, 1992
BIOPSY FORCEPS
K914497 · FCL
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 87d
Cleared Jan 03, 1992
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
K914555 · DRE
Med Institute, Inc.
Cardiovascular · 88d
Cleared Jan 03, 1992
GRIESHABER TWO FUNCTION MANIPULATOR
K914585 · EQH
Grieshaber & Co.
Ear, Nose, Throat · 79d
Cleared Jan 03, 1992
GRIESHABER THREE FUNCTION MANIPULATOR
K914586 · EQH
Grieshaber & Co.
Ear, Nose, Throat · 79d
Cleared Jan 03, 1992
COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY
K915083 · JBQ
Kabi Pharmacia, Inc.
Hematology · 52d
Cleared Jan 02, 1992
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · JDI
Biomet, Inc.
Orthopedic · 254d
Cleared Jan 02, 1992
LANDMARK ADD-A-LUMEN CATHETER KIT
K912358 · FOZ
Menlo Care, Inc.
General Hospital · 219d
Cleared Jan 02, 1992
TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT
K913114 · FMF
Gerard Medical Enterprises, Inc.
General Hospital · 178d
Cleared Jan 02, 1992
BIO-RAD TOTAL PROTEIN TEST KIT
K913315 · CEF
Bio-Rad
Chemistry · 161d
Cleared Jan 02, 1992
IDEAS' PORT
K913602 · FMF
Ideal Medical, Inc.
General Hospital · 142d
Cleared Jan 02, 1992
CLINICAL HANDMASTER SYSTEM OR CHMS
K914436 · LBB
Exos Medical Products
Neurology · 90d