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
69601–69624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2004
RESMED HOSPITAL NASAL MASK
K040566 · BZD
Resmed, Ltd.
Anesthesiology · 29d
Cleared Apr 02, 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
K040665 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 02, 2004
MESACUP TEST PR-3
K040711 · MOB
Rhigene, Inc.
Immunology · 15d
Cleared Apr 02, 2004
TRUST
K040718 · CAF
Dhd Healthcare Corp.
Anesthesiology · 14d
Cleared Apr 02, 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · JOJ
Advanced Sterilization Products
General Hospital · 10d
Cleared Apr 02, 2004
BRITESMILE MASKING CREAM
K040797 · EIE
Britesmile, Inc.
Dental · 4d
Cleared Apr 01, 2004
X-VIEW
K024186 · MUH
Sometech Corporation
Radiology · 469d
Cleared Apr 01, 2004
NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
K030784 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 386d
Cleared Apr 01, 2004
OSTEOSORB TACK FIXATION SYSTEM
K030989 · JEY
Noviace Corporation
Orthopedic · 370d
Cleared Apr 01, 2004
STRYKER RF ELECTRODES AND CANNULAE
K032406 · GXI
Stryker Instruments
Neurology · 241d
Cleared Apr 01, 2004
SYNTHES AFS
K032534 · NQW
Synthes Spine
Orthopedic · 230d
Cleared Apr 01, 2004
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601 · GXD
Valley Forge Scientific Corp.
Neurology · 220d
Cleared Apr 01, 2004
LUCENTLITE, MODEL IMD 010
K033072 · GEX
Industrial & Medical Design, Inc.
General & Plastic Surgery · 185d
Cleared Apr 01, 2004
ULTRAPRO MESH
K033337 · FTL
Ethicon, Inc.
General & Plastic Surgery · 167d
Cleared Apr 01, 2004
KYPHX HV-R, MODEL C01A
K033801 · NDN
Kyphon, Inc.
Orthopedic · 115d
Cleared Apr 01, 2004
MEDISIL SILICONE SHEETING
K040042 · MIB
Medisil Corporation
General & Plastic Surgery · 80d
Cleared Apr 01, 2004
PALOMAR LUXV HANDPIECE
K040081 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 77d
Cleared Apr 01, 2004
RABBIT
K040087 · KNW
Scion International, Inc.
Gastroenterology & Urology · 76d
Cleared Apr 01, 2004
QUIXX POSTERIOR RESTORATIVE
K040144 · EBF
Dentsply International
Dental · 70d
Cleared Apr 01, 2004
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K040240 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 58d
Cleared Apr 01, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K040369 · DZJ
Stryker Instruments
Dental · 48d
Cleared Apr 01, 2004
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 30d
Cleared Apr 01, 2004
MODIFICATION TO ACCULEAF
K040553 · IXI
Direx Systems Corp.
Radiology · 30d
Cleared Apr 01, 2004
CLICK-ON
K040633 · FPA
Unomedical A/S
General Hospital · 22d