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
67105–67128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2004
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · LOD
Exactech, Inc.
Orthopedic · 18d
Cleared Dec 27, 2004
CLINICAL ELECTRONIC THERMOMETER
K032434 · FLL
Cotronic Manufacturing
General Hospital · 509d
Cleared Dec 27, 2004
CALCIUM, AZO DYE REAGENT
K040972 · CJY
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
BUN REAGENT
K040973 · CDS
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GLUCOSE OXIDASE, GLUCOSE
K040974 · CGA
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GENCHEM CO2 ACID REAGENT
K040975 · JFL
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GENCHEM CREATININE REAGENT
K040976 · CGX
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
GENCHEM ELECTROLYTE BUFFER
K040977 · JGS
Genchem, Inc.
Chemistry · 257d
Cleared Dec 27, 2004
UNICRYL
K042288 · GAM
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 125d
Cleared Dec 27, 2004
SALICYLATE-SL ASSAY
K042329 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 122d
Cleared Dec 27, 2004
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50,...
K042362 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 118d
Cleared Dec 27, 2004
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902 · KXE
Stuckenbrock Medizintechnik GmbH
Orthopedic · 68d
Cleared Dec 27, 2004
CEMENTEK LV
K042911 · MQV
Teknimed, S.A.
Orthopedic · 67d
Cleared Dec 27, 2004
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947 · NDN
Arthrocare Corp.
Orthopedic · 62d
Cleared Dec 27, 2004
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
K043404 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Dec 23, 2004
LTU-904 PORTABLE LASER THERAPY UNIT
K030295 · NZY
Riancorp Pty, Ltd.
General & Plastic Surgery · 695d
Cleared Dec 23, 2004
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
K040778 · MNW
Tanita Corp. of America
Gastroenterology & Urology · 272d
Cleared Dec 23, 2004
SURGPLAN AND PANPLAN
K041078 · LLZ
Imaging Sciences Intl., Inc.
Radiology · 241d
Cleared Dec 23, 2004
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757 · HIB
Femspec LLC
Obstetrics & Gynecology · 177d
Cleared Dec 23, 2004
MTF ALLOGRAFT ANCHOR
K042038 · GAT
Musculoskeletal Transplant Foundation
General & Plastic Surgery · 147d
Cleared Dec 23, 2004
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
K042620 · IYO
Tetrad Corp.
Radiology · 87d
Cleared Dec 23, 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
K042985 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 55d
Cleared Dec 23, 2004
SOMATOM RESPIRATORY GATING
K043086 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Dec 23, 2004
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
K043090 · LZI
Phonic Ear, Inc.
Ear, Nose, Throat · 45d