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
52105–52128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2009
MTD 4000
K091540 · ITH
Mettler Electronics Corp.
Physical Medicine · 135d
Cleared Oct 08, 2009
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
K092014 · DYB
Onset Medical Corporation
Cardiovascular · 94d
Cleared Oct 08, 2009
PMD VIEWER
K092204 · LLZ
Spencer Technologies
Radiology · 78d
Cleared Oct 08, 2009
MODIFICATION TO FMRI HARDWARE SYSTEM
K092253 · LNH
Nordicneurolab
Radiology · 72d
Cleared Oct 08, 2009
BODY COMPOSITION ANALYZER, MODEL: IOI 353
K092431 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 62d
Cleared Oct 08, 2009
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
K092509 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 52d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
St Jude Medical
Cardiovascular · 48d
Cleared Oct 08, 2009
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · LIH
Well-Life Healthcare Limited
Neurology · 29d
Cleared Oct 08, 2009
MICROSELECTRON HDR V2, MODEL 105.999
K092804 · JAQ
Nucletron Corp.
Radiology · 27d
Cleared Oct 08, 2009
HOFFMAN XPRESS LINE EXTENSION
K092834 · KTT
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Oct 08, 2009
MAXIFLO, TAPERFLO
K092863 · DSY
Vascutek, Ltd.
Cardiovascular · 21d
Cleared Oct 08, 2009
IMAGEGRID RADIOLOGY VIEWER SYSTEM
K092949 · LLZ
Candelis, Inc.
Radiology · 14d
Cleared Oct 07, 2009
OR-LIGHT
K090724 · ONF
Yperion Technology
General & Plastic Surgery · 202d
Cleared Oct 07, 2009
TAKE 1
K091613 · ELW
Kerr Corp.
Dental · 126d
Cleared Oct 07, 2009
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
K091918 · OWB
Genoray Co., Ltd.
Radiology · 99d
Cleared Oct 07, 2009
ISPIRA RESUSCITATION UNIT
K092085 · BTL
Neoforce Group, Inc.
Anesthesiology · 90d
Cleared Oct 07, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092516 · LYZ
Zi BO Yuxiang Gloves Co., Ltd.
General Hospital · 51d
Cleared Oct 07, 2009
G-PROX ENDOSCOPIC GRASPER, MODEL 205333
K093018 · GAT
Usgi Medical
General & Plastic Surgery · 29d
Cleared Oct 06, 2009
BEGO SEMADOS S-LINE
K090716 · DZE
Bego Implant Systems GmbH & Co. KG
Dental · 202d
Cleared Oct 06, 2009
OSSEOLINK DENTAL IMPLANT SYSTEM
K091878 · DZE
Global Implant Solutions, LLC
Dental · 105d
Cleared Oct 06, 2009
NOBELPROCERA IMPLANT BRIDGE ZIRCONIA
K091907 · NHA
Nobel Biocare AB
Dental · 103d
Cleared Oct 06, 2009
INTERPLATE C
K092070 · KWQ
Rsb Spine, LLC
Orthopedic · 90d
Cleared Oct 06, 2009
BTI DENTAL IMPLANT TINY 2.5-3.0
K092112 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 84d
Cleared Oct 06, 2009
PHOTEX30 DIODE LASER SERIES: 980, 810, 940
K092197 · GEX
Biotex, Inc.
General & Plastic Surgery · 77d