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
128449–128472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 22, 1989
TAMPAX TAMPON
K896989 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 10d
Cleared Dec 22, 1989
KOTEX SECURITY TAMPONS (SEVERAL TYPE)
K896994 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 11d
Cleared Dec 22, 1989
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS
K897012 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 2d
Cleared Dec 21, 1989
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · KGI
Hologic, Inc.
Radiology · 297d
Cleared Dec 21, 1989
ARTECH TYPE SS SUBMERGED SCREW IMPLANT
K891346 · DZE
Artech Corp.
Dental · 286d
Cleared Dec 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892633 · LYY
Gobo Intl.
General Hospital · 255d
Cleared Dec 21, 1989
HEATED RESPIRATORY HUMIDIFIER
K892817 · BTT
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 248d
Cleared Dec 21, 1989
PATIENT EXAMINATION GLOVES
K893632 · LYY
Pro Asia, Inc.
General Hospital · 225d
Cleared Dec 21, 1989
ISODENT
K894058 · EIA
Eurodent, Inc.
Dental · 197d
Cleared Dec 21, 1989
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR
K894653 · KGC
Superior Biosystems, Inc.
Gastroenterology & Urology · 150d