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
118513–118536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1992
EXTENDO-BAC TABLE
K914769 · INW
Reinert Technics, Inc.
Physical Medicine · 78d
Cleared Jan 08, 1992
010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
K914828 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Jan 08, 1992
SUTTER MODEL 10000 LEG CPM DEVICE
K914860 · BXB
Sutter Corp.
Physical Medicine · 71d
Cleared Jan 08, 1992
VACUTAINER KIT
K914901 · GIM
Abbott Laboratories
Chemistry · 68d
Cleared Jan 08, 1992
DMI BLOD GAS ANALYZER/CARTRIDGE
K915087 · CHL
Diamond Medical, Inc.
Chemistry · 57d
Cleared Jan 08, 1992
CORVAC BLOOD COLLECTION TUBE
K915213 · GIM
Sherwood Medical Co.
Chemistry · 51d
Cleared Jan 08, 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · GKF
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Jan 07, 1992
FLEXIBLE AND RIGID URETEROTOME SYSTEM
K904939 · EZO
Olympus Corp.
Gastroenterology & Urology · 432d
Cleared Jan 07, 1992
DHD METERED DOSE INHALER (MDI) SPACER
K913326 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 166d
Cleared Jan 07, 1992
PATIENT EXAMINATION GLOVEWS
K913531 · LYY
Pt. Sarana Indoprotex
General Hospital · 152d
Cleared Jan 07, 1992
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
K913900 · BTM
Ventlab Corp.
Anesthesiology · 130d
Cleared Jan 07, 1992
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914515 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 1992
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914516 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 1992
CORE MEDICAL BIOPSY NEEDLE
K914732 · FCG
Core Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Jan 07, 1992
TC-1000, TC-1050 SYSTEM
K914805 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 75d
Cleared Jan 07, 1992
WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K914881 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 69d
Cleared Jan 07, 1992
WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
K914882 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 69d
Cleared Jan 07, 1992
PULLER OPTION FOR ETUDE(TM)
K914891 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 68d
Cleared Jan 07, 1992
ASP-IRRATOR
K914997 · GCJ
Conmedcorp
General & Plastic Surgery · 61d
Cleared Jan 07, 1992
ORS-1000
K915427 · JRM
Mnlase, Inc.
Chemistry · 36d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.
K915480 · DWD
Bd Becton Dickinson Vacutainer...
Cardiovascular · 32d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481 · DWD
Bd Becton Dickinson Vacutainer...
Cardiovascular · 32d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · DWD
Bd Becton Dickinson Vacutainer...
Cardiovascular · 32d
Cleared Jan 06, 1992
MOSSIMO OPTIC EYEWEAR
K912509 · HQY
Mossimo, Inc.
Ophthalmic · 214d