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

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175,820 results
36865–36888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2014
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT...
K140581 · PIO
Cedic S.R.L.
Gastroenterology & Urology · 225d
Cleared Oct 17, 2014
MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI -...
K140728 · DZE
Ditron Precision, Ltd.
Dental · 207d
Cleared Oct 17, 2014
HALO AMBULATORY INFUSION SYSTEM
K140783 · FRN
Zyno Medical, LLC
General Hospital · 200d
Cleared Oct 17, 2014
Z1 CPAP SYSTEM
K140929 · BZD
Human Design Medical, LLC
Anesthesiology · 191d
Cleared Oct 17, 2014
ADVANTAGE
K141152 · BZD
Stevenson Industries, Inc.
Anesthesiology · 165d
Cleared Oct 17, 2014
MATRIXWAVE MMF SYSTEM
K141165 · JEY
Synthes USA Products, LLC
Dental · 164d
Cleared Oct 17, 2014
GLIDE DEVICE
K141242 · OHT
Home Skinovations , Ltd.
General & Plastic Surgery · 156d
Cleared Oct 17, 2014
EXPEL APD DRAINAGE CATHETER SYSTEM
K141335 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 149d
Cleared Oct 17, 2014
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL...
K141344 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 148d
Cleared Oct 17, 2014
ELECSYS FOLATE III
K141426 · CGN
Roche Diagnostics
Chemistry · 140d
Cleared Oct 17, 2014
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141579 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 126d
Cleared Oct 17, 2014
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
K141600 · MQV
Pioneer Surgical Technology, Inc....
Orthopedic · 123d
Cleared Oct 17, 2014
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
K141742 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 112d
Cleared Oct 17, 2014
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR...
K141917 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 94d
Cleared Oct 17, 2014
PARIETENE MACROPOROUS MESH
K142091 · FTL
Sofradim Production
General & Plastic Surgery · 77d
Cleared Oct 17, 2014
T-PIECE RESUSCITATOR
K142096 · BTL
Mercury Medical
Anesthesiology · 77d
Cleared Oct 17, 2014
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
K142220 · CHL
Nova Biomedical Corporation
Chemistry · 66d
Cleared Oct 17, 2014
XprESS Multi-Sinus Dilation Tool
K142252 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 17, 2014
Sherlock 3CG Tip Positioning System Stylet
K142267 · LJS
C.R. Bard, Inc.
General Hospital · 63d
Cleared Oct 17, 2014
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS,...
K142589 · MAX
Titan Spine, LLC
Orthopedic · 32d
Cleared Oct 17, 2014
Merit 10mL Syringe
K142636 · FMF
Merit Medical Systems, Inc.
General Hospital · 30d
Cleared Oct 17, 2014
Antegrade LeMills Valvulotome
K142660 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 29d
Cleared Oct 16, 2014
NDX DORSAL APPLIANCE
K133390 · LRK
Institute For Quality Resource...
Dental · 345d
Cleared Oct 16, 2014
PIEZOMED
K133488 · DZI
W&H Dentalwerk Buermoos GmbH
Dental · 337d