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
35953–35976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2015
OMNI Interface Acetabular System
K142201 · LPH
Omnlife Science
Orthopedic · 168d
Cleared Jan 26, 2015
NewTom 5G
K142222 · JAK
Qr S.R.L.
Radiology · 166d
Cleared Jan 26, 2015
Aviator Anterior Cervical Plate (ACP) System
K142237 · KWQ
Stryker Corporation
Orthopedic · 166d
Cleared CT Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
K142284 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 161d
Cleared Jan 26, 2015
Benchmark Intracranial Access System
K142321 · DQY
Penumbra, Inc.
Cardiovascular · 160d
Cleared Jan 26, 2015
ZEL TIQ CoolSculpting System
K142491 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 144d
Cleared Jan 26, 2015
Trident® Tritanium® PST® Acetabular Shells
K142606 · LPH
Mako Surgical Corp.
Orthopedic · 133d
Cleared Jan 26, 2015
CB PROT II Posterior Spinal System
K142655 · MNH
Chin Bone Technique Corp
Orthopedic · 130d
Cleared Jan 26, 2015
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
K143059 · NGX
Tone-A-Matic International, Inc.
Physical Medicine · 94d
Cleared Jan 26, 2015
Activ Ankle Locking Plating System
K143061 · HRS
Newclip Technics
Orthopedic · 94d
Cleared Jan 26, 2015
KA01 Chitosan Wound Dressing
K143124 · KGN
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 87d
Cleared Jan 26, 2015
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact...
K143151 · FRO
Bsn Medical GmbH
General & Plastic Surgery · 84d
Cleared Jan 26, 2015
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK...
K143163 · OVD
Stryker Corporation
Orthopedic · 84d
Cleared Jan 26, 2015
VERTA Corpectomy Cage
K143490 · MQP
Camber Spine
Orthopedic · 49d
Cleared Jan 23, 2015
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
K133659 · MKJ
Philips Medical Systems
Cardiovascular · 422d
Cleared Jan 23, 2015
WOUND DRESSING WITH MANUKA HONEY
K133729 · FRO
Manuka Health New Zealand , Ltd.
General & Plastic Surgery · 413d
Cleared Jan 23, 2015
ELECTRODE FOR URINARY INCONTINENCE
K140265 · KPI
Guangzhou Finecure Medical Equipment...
Gastroenterology & Urology · 354d
Cleared Jan 23, 2015
AMSEL OCCLUDER DEVICE
K140932 · FZP
Amsel Medical Corporation
General & Plastic Surgery · 287d
Cleared Jan 23, 2015
MAMMAPRINT FFPE
K141142 · NYI
Agendia
Pathology · 266d
Cleared Jan 23, 2015
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K141448 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 235d
Cleared Jan 23, 2015
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
K141511 · GEX
Cynosure, Inc.
General & Plastic Surgery · 228d
Cleared Jan 23, 2015
CAREFUSION GOLD TISSUE MARKER
K141722 · NEU
Care Fusion
General & Plastic Surgery · 212d
Cleared Jan 23, 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · MQV
Biocomposites, Ltd.
Orthopedic · 200d
Cleared Jan 23, 2015
STGC-LORDOTIC
K142030 · MQP
Cardinal Spine, LLC
Orthopedic · 182d