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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
77857–77880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2001
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 28d
Cleared Dec 07, 2001
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID...
K013734 · JJY
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared Dec 07, 2001
CYBERMED, INC., V-WORKS
K013878 · LLZ
Cybermed, Inc.
Radiology · 14d
Cleared Dec 07, 2001
DAYLITE XENON LIGHT SOURCES
K013880 · GCT
Designs For Vision, Inc.
Gastroenterology & Urology · 14d
Cleared Dec 07, 2001
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · FRG
Riley Medical, Inc.
General Hospital · 780d
Cleared Dec 06, 2001
PLASMA SPRAYED SHOULDER
K003324 · KWS
Encore Orthopedics, Inc.
Orthopedic · 408d
Cleared Dec 06, 2001
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
K011893 · LPL
Contact Color Srl
Ophthalmic · 171d
Cleared Dec 06, 2001
BAYER ADVIA IMS SYSTEM
K012337 · DCN
Bayer Corp.
Chemistry · 135d
Cleared Dec 06, 2001
REPROCESSED SOFT TISSUE ABLATORS
K012631 · GEI
Alliance Medical Corp.
General & Plastic Surgery · 115d
Cleared Dec 06, 2001
MEDIGROUP KEY TUBE
K013017 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 2001
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
K013027 · BTI
Respironics Healthscan, Inc.
Anesthesiology · 87d
Cleared Dec 06, 2001
PALOMAR SLP 1000
K013028 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 87d
Cleared Dec 06, 2001
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
K013047 · GEX
Mojca Valijavec
General & Plastic Surgery · 87d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9084
K013407 · DJG
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9079
K013408 · DJG
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9074
K013409 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9069
K013412 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
K013650 · MUH
Sirona Dental Systems GmbH
Radiology · 30d
Cleared Dec 06, 2001
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K013659 · MUH
Sirona Dental Systems GmbH
Radiology · 30d
Cleared Dec 06, 2001
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
K013683 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Dec 06, 2001
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · IOR
Medline Industries, Inc.
Physical Medicine · 23d
Cleared Dec 06, 2001
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789 · DQY
Boston Scientific, Target
Cardiovascular · 22d
Cleared Dec 06, 2001
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · HAW
Elekta Instrument AB
Neurology · 15d