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
44281–44304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · QSY
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 239d
Cleared May 23, 2012
SOMATOM PERSPECTIVE
K113287 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared May 23, 2012
HIGH FIVE
K113440 · LZA
Central Medicare Sdn Bhd
General Hospital · 184d
Cleared May 23, 2012
REACH SURGICAL STAPLERS
K120179 · GDW
Reach Surgical, Inc.
General & Plastic Surgery · 124d
Cleared May 23, 2012
PUSH-ON NEEDLE 30GX8MM
K120191 · FMI
Scandinavian Health Limited
General Hospital · 121d
Cleared May 23, 2012
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0,...
K120284 · NEW
Coloplast A/S
General & Plastic Surgery · 113d
Cleared May 23, 2012
VANTAGE TITAN 3T
K120487 · LNH
Toshibamedical Systems Corporation
Radiology · 96d
Cleared May 23, 2012
TEMPUS CERVICAL PLATE SYSTEM
K120515 · KWQ
Neurostructures, LLC
Orthopedic · 92d
Cleared May 23, 2012
VILET VILET QUICK
K120556 · GAM
Riverpoint Medical
General & Plastic Surgery · 89d
Cleared May 23, 2012
SOMATOM DEFINITION EDGE
K120579 · JAK
Siemens Medical Systems, Inc.
Radiology · 86d
Cleared May 23, 2012
PALOMAR VECTUS LASER
K120622 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 83d
Cleared May 23, 2012
LEXUS CERVICAL FIXATION SYSTEM
K120879 · MNI
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 23, 2012
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN...
K120934 · KGO
Cardinal Health, Inc.
General Hospital · 56d
Cleared May 23, 2012
MANUKA IG
K120976 · FRO
Links Medical Products, Inc.
General & Plastic Surgery · 51d
Cleared May 23, 2012
AERODR X70
K121109 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 41d
Cleared May 23, 2012
MANUKA FILL
K121227 · FRO
Links Medical Products, Inc.
General & Plastic Surgery · 30d
Cleared May 23, 2012
MYLABSOGNO
K121384 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared May 22, 2012
VIEWRAY SYSTEM
K111862 · IYE
Viewray, Incorporated
Radiology · 327d
Cleared May 22, 2012
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K112527 · MQB
Meridian Medical Systems, LLC
Radiology · 265d
Cleared May 22, 2012
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH...
K112881 · GWF
Nexstim OY
Neurology · 235d
Cleared May 22, 2012
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
K113103 · PNO
Rex Medical
Cardiovascular · 216d
Cleared May 22, 2012
TEMPSPAN CLEAR MATRIX
K120013 · ELW
Pentron Clinical
Dental · 140d
Cleared May 22, 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE...
K120042 · LFR
Taidoc Technology Corporation
Chemistry · 138d
Cleared May 22, 2012
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED...
K120443 · FPA
Baxter Healthcare Corporation - Renal...
General Hospital · 98d