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
131953–131976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1989
NEEDLE STICK
K885122 · FMI
Poncy, Inc.
General Hospital · 95d
Cleared Mar 14, 1989
MEDSURG GREENE NEEDLE
K885145 · DWO
Medsurg Industries, Inc.
General & Plastic Surgery · 89d
Cleared Mar 14, 1989
MENTOR MDS
K885155 · IYN
Imex
Radiology · 89d
Cleared Mar 14, 1989
KODAK MULTILOADER 700
K885207 · IXW
Eastman Kodak Company
Radiology · 85d
Cleared Mar 14, 1989
ATTACHABLE LANZ (TENTATIVE)
K885216 · BSK
Mallinckroot, Inc.
Anesthesiology · 85d
Cleared Mar 14, 1989
RT6800 ECHOCARDIOGRAPHY SYSTEM
K885228 · IYO
General Electric Co.
Radiology · 84d
Cleared Mar 14, 1989
PERSONAL TRANSFER SYSTEM
K885270 · FNG
Columbus Mckinnon Corp.
General Hospital · 82d
Cleared Mar 14, 1989
GIARDIA STOOL ANTIGEN TEST KIT
K890003 · KHW
Lmd Laboratories
Microbiology · 70d
Cleared Mar 14, 1989
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
K890193 · BYG
Puritan Bennett Corp.
Anesthesiology · 55d
Cleared Mar 14, 1989
BAG DECANTER
K890272 · KPE
Superior Medical Products
General Hospital · 55d
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