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
127849–127872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1989
SAFE-1 VENOUS RESERVOIR
K893705 · DTN
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d
Cleared Dec 22, 1989
FUJITENS III
K893874 · GZQ
Altoona Medical Supply
Neurology · 210d
Cleared Dec 22, 1989
AMBULATORY INFUSION SYSTEM AND ACCESSORIES
K894028 · FRN
Patient Solutions, Inc.
General Hospital · 199d
Cleared Dec 22, 1989
ACTILLUME
K894044 · GWQ
Ambulatory Monitoring, Inc.
Neurology · 198d
Cleared Dec 22, 1989
FIRST IMPRESSION TM
K894282 · ELW
Coe Laboratories, Inc.
Dental · 182d
Cleared Dec 22, 1989
RADIOSCOPE OR MAMMOSCOPE
K894412 · LMA
Vision Ten, Inc.
Radiology · 158d
Cleared Dec 22, 1989
MODEL AO-800PA CO2 MODULE
K894691 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 151d
Cleared Dec 22, 1989
TECA NEUROMAPPER 386
K894889 · OLT
Teca, Inc.
Neurology · 143d
Cleared Dec 22, 1989
CEEGRAPH
K895125 · GWQ
Bio-Logic Systems Corp.
Neurology · 129d
Cleared Dec 22, 1989
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · CJA
Hichem Diagnostics
Chemistry · 107d
Cleared Dec 22, 1989
ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
K895763 · KXO
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 87d
Cleared Dec 22, 1989
ORIGINAL TICK KIT/1ST AID KIT
K895767 · LRR
Tick Kit, Inc.
General & Plastic Surgery · 86d
Cleared Dec 22, 1989
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · BYT
Respironics, Inc.
Anesthesiology · 80d
Cleared Dec 22, 1989
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
K895853 · BZO
Sechrist Industries, Inc.
Anesthesiology · 80d
Cleared Dec 22, 1989
STANDARD NEBULIZER HEATER
K895913 · CAF
Seamless Div., Professional Medical...
Anesthesiology · 73d
Cleared Dec 22, 1989
TOOTH SHADE RESIN
K895976 · EBF
G-C Intl. Corp.
Dental · 71d
Cleared Dec 22, 1989
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
K896030 · CCK
Hewlett-Packard Co.
Anesthesiology · 66d
Cleared Dec 22, 1989
THE SMITHCOT
K896261 · FPP
Ram Marketing, Inc.
General Hospital · 53d
Cleared Dec 22, 1989
V2465P X-RAY IMAGE INTENSIFIER
K896331 · JAA
Hamamatsu Photonics K.K.
Radiology · 50d
Cleared Dec 22, 1989
MODEL SPINE SURVEYOR-PLUS
K896336 · LNH
Medical Advances, Inc.
Radiology · 49d
Cleared Dec 22, 1989
GE TARGET SERIES 2
K896353 · KPQ
GE Medical Systems
Radiology · 46d
Cleared Dec 22, 1989
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
K896370 · GXZ
Chalgren Enterprises, Inc.
Neurology · 46d
Cleared Dec 22, 1989
ASPECT GAMMA CAMERA
K896458 · KPS
Digital Scintigraphics, Inc.
Radiology · 39d
Cleared Dec 22, 1989
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL
K896511 · KPY
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 38d