Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
39409–39432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · NBW
ACON Laboratories, Inc.
Chemistry · 318d
Cleared Dec 20, 2013
ELECTROTHERAPY DEVICE (COMBO UNIT)
K130691 · IPF
Guangzhou Finecure Medical Equipment...
Physical Medicine · 282d
Cleared Dec 20, 2013
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
K131510 · ELW
Blackwell Device Consulting
Dental · 210d
Cleared Dec 20, 2013
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · DSB
Conmed Corporation
Cardiovascular · 186d
Cleared Dec 20, 2013
KC 300 SURGICAL MASK
K131879 · FXX
Kimberly-Clark Corp.
General Hospital · 179d
Cleared Dec 20, 2013
ELECTRONIC PULSE MASSAGER
K131933 · NUH
Gurin Products, LLC
Neurology · 176d
Cleared Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
K131935 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 176d
Cleared Dec 20, 2013
IMAGE1 SPIES
K131953 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 176d
Cleared Dec 20, 2013
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
K132026 · MHX
Mindray DS USA, Inc.
Neurology · 172d
Cleared Dec 20, 2013
MULTI ANGLED ABUTMENT SYSTEM
K132067 · NHA
Hiossen, Inc.
Dental · 170d
Cleared Dec 20, 2013
BARLE TISSUE ADHESIVE 2
K132243 · MPN
Advanced Medical Solutions...
General & Plastic Surgery · 155d
Cleared Dec 20, 2013
NIVATOPIC PLUS
K132329 · FRO
Nivagen Pharmaceuticals, Inc.
General & Plastic Surgery · 147d
Cleared Dec 20, 2013
XVWEB
K132342 · LLZ
Apteryx, Inc.
Radiology · 147d
Cleared Dec 20, 2013
IDEAL
K132428 · HSB
Jiangsu Ideal Medical Science &...
Orthopedic · 137d
Cleared Dec 20, 2013
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
K132530 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 130d
Cleared Dec 20, 2013
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
K132555 · PCN
The Binding Site
Immunology · 128d
Cleared Dec 20, 2013
SUNETICS CLINICAL BIO-STIMULATION LASER
K132646 · OAP
Sunetics International Marketing...
General & Plastic Surgery · 116d
Cleared Dec 20, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K132652 · DQY
Sequent Medical, Inc.
Cardiovascular · 116d
Cleared Dec 20, 2013
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
K132671 · JCX
Stryker Corporation
General Hospital · 115d
Cleared Dec 20, 2013
BIOMARC FIDUCIAL MARKER
K132708 · NEU
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 113d
Cleared Dec 20, 2013
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
K132715 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 112d
Cleared Dec 20, 2013
SEAL BIOPSY VALVE - REUSABLE
K132776 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 106d
Cleared Dec 20, 2013
INFIX ANTERIOR LUMBAR SYSTEM
K132790 · MAX
Zimmer Spine, Inc.
Orthopedic · 105d
Cleared Dec 20, 2013
AIRFIT N10
K132887 · BZD
Resmed, Ltd.
Anesthesiology · 95d