FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132553–132576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1989
MICK 200-TP AND MICK TP NEEDLE
K890341 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 50d
Cleared Mar 14, 1989
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · CAH
Puritan Bennett Corp.
General Hospital · 48d
Cleared Mar 14, 1989
MEDRAD SCPD 1000
K890394 · LNH
Medrad, Inc.
Radiology · 48d
Cleared Mar 14, 1989
THE PATHFINDER SYSTEM
K890483 · IZH
Denmark Assoc.
Radiology · 42d
Cleared Mar 14, 1989
MED-A-CALL ASSIST DEVICE
K890596 · IQA
Silent Call Corp.
Physical Medicine · 46d
Cleared Mar 14, 1989
O.R. TOWELS (STERILE)
K890709 · KKX
Cypress Medical Products, Ltd.
General Hospital · 29d
Cleared Mar 14, 1989
DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS
K890710 · GXY
Somatics, Inc.
Neurology · 29d
Cleared Mar 14, 1989
SC-1000 WITH SUFFIXES (SCAN CONVERTER)
K890745 · JAA
Eigen
Radiology · 29d
Cleared Mar 14, 1989
STERILE LAPAROTOMY SPONGES
K890770 · EFQ
Cypress Medical Products, Ltd.
General & Plastic Surgery · 28d
Cleared Mar 14, 1989
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · FXX
3M Company
General Hospital · 28d
Cleared Mar 14, 1989
SONY VIDEO GRAPHIC PRINTER UP-850
K890826 · KQM
Sony Corp. of America
General & Plastic Surgery · 25d
Cleared Mar 14, 1989
TC SYSTEM-HANDLE
K890866 · FTA
Transmedical Corp.
General & Plastic Surgery · 21d
Cleared Mar 14, 1989
TC SYSTEM-COVER
K890867 · FTA
Transmedical Corp.
General & Plastic Surgery · 21d
Cleared Mar 14, 1989
PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD
K890878 · JAA
U.S. Imaging, Inc.
Radiology · 21d
Cleared Mar 14, 1989
VITALON MATRESS MASSAGE MODEL M-MX
K890923 · ISA
Nexus Co. , Ltd. C/O Yama Trans Co. ,...
Physical Medicine · 18d
Cleared Mar 14, 1989
THERMO-PACK
K890924 · IMD
Medical Manufacturers, Inc.
Physical Medicine · 18d
Cleared Mar 14, 1989
STERILE PATIENT EXAMINATION GLOVE
K891103 · LYY
Boston Medical Corp.
General Hospital · 25d
Cleared Mar 13, 1989
PROGENE MICROALBUMINURIA SCREEN
K882538 · JIR
Progene Corp.
Chemistry · 265d
Cleared Mar 13, 1989
AEGIS(TM) CONDOMS
K883409 · HIS
Green Cross Medical Supplies Corp.
Obstetrics & Gynecology · 210d
Cleared Mar 13, 1989
ROS-TR SYSTEM
K884140 · DZE
Ross Systems C/O...
Dental · 164d
Cleared Mar 13, 1989
EDWARDS DISPOSABLE ARTHROSCOPY CANNULA
K884301 · HRX
Baxter Healthcare Corp
Orthopedic · 151d
Cleared Mar 13, 1989
LEONARD MEDICAL 1.7MM ARTHROSCOPE
K884314 · HRX
Leonard Medical, Inc.
Orthopedic · 151d
Cleared Mar 13, 1989
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940 · GGP
American Diagnostic Corp.
Hematology · 105d
Cleared Mar 13, 1989
ACTICLOT C KIT
K884941 · GGP
American Diagnostic Corp.
Hematology · 105d