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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123241–123264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632 · DTN
Medtronic Vascular
Cardiovascular · 129d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807 · LFZ
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Dec 17, 1990
ARGENCO 26B
K903971 · EJS
Argen Precious Metals, Inc.
Dental · 111d
Cleared Dec 17, 1990
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
K904020 · ESD
3M Company
Ear, Nose, Throat · 109d
Cleared Dec 17, 1990
L.P.I. LASER DELIVERY SYSTEM
K904331 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 87d
Cleared Dec 17, 1990
SI-PRO
K904389 · EYF
David F. Trungale
General & Plastic Surgery · 82d
Cleared Dec 17, 1990
ANTI-HUMAN LEU-2A (CD8) PE
K904390 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 83d
Cleared Dec 17, 1990
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
K904454 · GJS
International Technidyne Corp.
Hematology · 91d
Cleared Dec 17, 1990
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
K904601 · DRS
Advance Medical Designs, Inc.
Cardiovascular · 68d
Cleared Dec 17, 1990
CENTAURI YAG LASER SYST, OPHTHAMOLOGY
K904630 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 69d
Cleared Dec 17, 1990
QUALITONE ITE GENESIS
K904731 · ESD
Qualitone
Ear, Nose, Throat · 61d
Cleared Dec 17, 1990
OSADA ENDEX
K904742 · LQY
Osada Electric Co., Ltd.
Dental · 60d
Cleared Dec 17, 1990
CRI STEERABLE CATHETER CONTROL SYSTEM
K904787 · DXX
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 55d
Cleared Dec 17, 1990
MEWISSEN CATHETER
K904788 · DQO
Boston Scientific Corp
Cardiovascular · 55d
Cleared Dec 17, 1990
DENTAL VACUUM INJECTION TRAY
K904914 · KMT
The Lebanon Vac-Tray Corp.
Dental · 47d
Cleared Dec 17, 1990
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · DWX
Baxter Healthcare Corp
Cardiovascular · 46d
Cleared Dec 17, 1990
PSG HEMOSTATIC CONTROL VALVE
K904959 · DQO
Peripheral Systems Group
Cardiovascular · 42d
Cleared Dec 17, 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077 · LFZ
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078 · LFZ
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
SAF FIXATIVE
K905120 · LIO
Gibson Laboratories, Inc.
Microbiology · 33d
Cleared Dec 17, 1990
DW 235
K905205 · EJJ
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 17, 1990
MONOBOND S
K905220 · EBF
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 17, 1990
SPECIAL BOND II
K905221 · EBF
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 17, 1990
SCRIBBON
K905382 · JES
Varnum Corp.
Dental · 18d