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
48337–48360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2011
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K102892 · FIP
Aqua Sciences, Inc.
Gastroenterology & Urology · 126d
Cleared Feb 03, 2011
ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
K103020 · NHA
Atlantis Components, Inc.
Dental · 114d
Cleared Feb 03, 2011
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
K103233 · LZO
Howmedica Osteonics Corp.
Orthopedic · 93d
Cleared Feb 03, 2011
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
K103309 · MAI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 85d
Cleared Feb 03, 2011
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K103561 · HQD
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Feb 03, 2011
INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
K110045 · MAX
Vertebral Technologies, Inc.
Orthopedic · 28d
Cleared Feb 02, 2011
SURGIAID
K100927 · KGN
Maxigen Biotech, Inc.
General & Plastic Surgery · 303d
Cleared Feb 02, 2011
HYPO CLENZ WOUND WASH MODEL 100 PPM
K100948 · FRO
Nevoa Life Sciences, LLC
General & Plastic Surgery · 302d
Cleared Feb 02, 2011
NASAL CEASE
K102742 · QSY
Catalina, Inc.
General & Plastic Surgery · 133d
Cleared Feb 02, 2011
SIGNATURE PLANNER
K102795 · JWH
Materialise NV
Orthopedic · 128d
Cleared Feb 02, 2011
PEDIACYN ATOPIC DERMATITIS HYDROGEL
K102945 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 121d
Cleared Feb 02, 2011
TALON SPINAL SYSTEM
K102995 · MNI
Spine360
Orthopedic · 117d
Cleared Feb 02, 2011
ULTICARE SAFETY INSULIN SYRINGE
K103011 · MEG
Ulti-Med Intl., Inc.
General Hospital · 113d
Cleared Feb 02, 2011
VASCULAIRE COMPRESSION SYSTEM
K103113 · JOW
Venous Health Systems, Inc.
Cardiovascular · 104d
Cleared Feb 02, 2011
ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
K103143 · DYB
Arstasis, Inc.
Cardiovascular · 100d
Cleared Feb 02, 2011
PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
K103190 · EBF
Silmet , Ltd.
Dental · 97d
Cleared Feb 02, 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · KCT
Entellus Medical, Inc.
General Hospital · 93d
Cleared Feb 02, 2011
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K103347 · DSY
Intervascular Sas
Cardiovascular · 79d
Cleared Feb 02, 2011
SECURVIEW DX DIAGNOSTIC WORKSTATION
K103385 · LLZ
Hologic, Inc.
Radiology · 76d
Cleared Feb 02, 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION...
K103387 · JJW
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Feb 02, 2011
POLARIS SPINAL SYSTEM
K103393 · KWQ
Biomet Spine
Orthopedic · 75d
Cleared Feb 02, 2011
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
K103506 · MOS
Imris, Inc.
Radiology · 65d
Cleared Feb 02, 2011
PET-512MC TRANSESOPHAGEAL TRANSDUCER
K103629 · ITX
Toshiba America Medical Systems, In.C
Radiology · 51d
Cleared Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K110009 · DQX
Cook, Inc.
Cardiovascular · 30d