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
37009–37032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2014
Operating Room Light Handle Adapter
K142386 · FTA
Litex Manufacturing, Inc.
General & Plastic Surgery · 33d
Cleared Sep 26, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K131817 · LNS
Osmunda Medical Device Consulting...
Gastroenterology & Urology · 463d
Cleared Sep 26, 2014
CLYDESDALE(R) SPINAL SYSTEM
K133577 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 309d
Cleared Sep 26, 2014
MEDLINE NEURO SPONGE
K140369 · HBA
Medline Industries, Inc.
Neurology · 224d
Cleared Sep 26, 2014
OPERA SWING
K140380 · JAA
General Medical Merate S.P.A
Radiology · 224d
Cleared Sep 26, 2014
SINGLE-SITE WRISTED NEEDLE DRIVER
K141075 · NAY
Intuitive Surgical
General & Plastic Surgery · 154d
Cleared Sep 26, 2014
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
K141097 · GDW
Touchstone International Medical...
General & Plastic Surgery · 151d
Cleared Sep 26, 2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
K141113 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 149d
Cleared Sep 26, 2014
AERODR SYSTEM 2
K141271 · MQB
Konica Minolta, Inc.
Radiology · 134d
Cleared Sep 26, 2014
PROVOX FREEHANDS FLEXIVOICE
K141380 · EWL
Atos Medical AB
Ear, Nose, Throat · 122d
Cleared Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490 · JAQ
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Sep 26, 2014
PERFRACTION
K141800 · IYE
Sun Nuclear Corporation
Radiology · 85d
Cleared Sep 26, 2014
PRO-LINK WEDGE SYSTEM
K141905 · HRS
Life Spine
Orthopedic · 73d
Cleared Sep 26, 2014
STRYKER S2 DRILL
K141935 · ERL
Stryker Corporation
Ear, Nose, Throat · 71d
Cleared Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA...
K142085 · LNH
Ge Medical Systems, LLC
Radiology · 57d
Cleared Sep 26, 2014
HEMASORB Resorbable Hemostatic Bone Putty
K142339 · MTJ
Orthocon, LLC
General & Plastic Surgery · 36d
Cleared Sep 26, 2014
I.T.S. Hand Locking Plates System - HLS
K142418 · HRS
I.T.S. GmbH
Orthopedic · 29d
Cleared Sep 25, 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · JAK
Philips Medical Systems
Radiology · 304d
Cleared Sep 25, 2014
PHANTOM XL INSULATED DILATORS
K140088 · PDQ
Tedan Surgical Innovations, LLC
Neurology · 254d
Cleared Sep 25, 2014
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
K140378 · GEX
Omniguide, Inc.
General & Plastic Surgery · 223d
Cleared Sep 25, 2014
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
K140670 · ONF
Ellipse A/S
General & Plastic Surgery · 191d
Cleared Sep 25, 2014
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · GAQ
Demetech Corp.
General & Plastic Surgery · 160d
Cleared Sep 25, 2014
PTA BALLOON DILATATION CATHETER
K141150 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Sep 25, 2014
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
K141358 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 125d