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
47425–47448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2011
SURESIGNS VS2 VITAL SIGNS MONITOR
K111114 · DXN
Philips Medical Systems
Cardiovascular · 29d
Cleared May 20, 2011
HYDROFIX VASO SHIELD
K111137 · OMR
Mimedx Group, Inc.
Cardiovascular · 28d
Cleared May 19, 2011
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C...
K100547 · LCP
Seppim S.A.S.
Chemistry · 448d
Cleared May 19, 2011
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS...
K102993 · CDT
Seppim S.A.S.
Chemistry · 223d
Cleared May 19, 2011
UNIMAX SUCTION IRRIGATION SET
K103509 · GCJ
Unimax Medical Systems, Inc.
General & Plastic Surgery · 171d
Cleared May 19, 2011
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
K103822 · MTJ
Synthes USA Products, LLC
General & Plastic Surgery · 140d
Cleared May 19, 2011
ROG KNOTLESS SUTURE ANCHOR
K110230 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 113d
Cleared May 19, 2011
ZENIUS SPINAL SYSTEM
K110283 · MNI
Medyssey Co, Ltd.
Orthopedic · 107d
Cleared May 19, 2011
ADHESIVE EXL-759
K110302 · KLE
3M Espe AG
Dental · 106d
Cleared May 19, 2011
CERAMIC BRACKETS
K110335 · NJM
Ortho Organizers, Inc.
Dental · 104d
Cleared May 19, 2011
STRYKER PATIENT SPECIFIC CUTTING GUIDE
K110533 · MBH
Stryker Corp.
Orthopedic · 84d
Cleared May 19, 2011
ARK CARE DIABETES MANAGMENT SYSTEM
K110709 · NBW
Arkray Factory USA, Inc.
Chemistry · 66d
Cleared May 19, 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039 · HRS
Zimmer, Inc.
Orthopedic · 35d
Cleared May 18, 2011
VIDAS TOXO IGG AVIDITY
K101946 · LGD
bioMerieux, Inc.
Microbiology · 310d
Cleared May 18, 2011
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY,...
K102733 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 238d
Cleared May 18, 2011
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
K103377 · DQX
Brivant, Ltd.
Cardiovascular · 182d
Cleared May 18, 2011
SHASER IPL HAIR REMOVAL SYSTEM
K103560 · ONF
Shaser, Inc.
General & Plastic Surgery · 166d
Cleared May 18, 2011
MITRA-LIFT
K103812 · KRH
Sciencity Co., Ltd.
Cardiovascular · 140d
Cleared May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
K110006 · NFJ
Ophthalmic Imaging Systems
Ophthalmic · 135d
Cleared May 18, 2011
ROG SUTURE ANCHOR 5.5MM, 2.9MM
K110229 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 112d
Cleared May 18, 2011
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
K110574 · HRS
Biomet Microfixation, Inc.
Orthopedic · 78d
Cleared May 18, 2011
TIGERPAW SYSTEM II
K111064 · GDW
Laax, Inc.
General & Plastic Surgery · 30d
Cleared May 17, 2011
COLONCAD API 3.1
K083423 · NWE
Medicsight Plc
Radiology · 909d
Cleared May 17, 2011
DASH KNEE
K102251 · OLO
Brainlab AG
Orthopedic · 281d