FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
7345–7368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2024
Cochlear Osia System
K240155 · PFO
Cochlear Americas
Ear, Nose, Throat · 90d
Cleared Apr 18, 2024
zLOCK Lumbar Facet Fixation System
K240085 · MRW
Zygofix , Ltd.
Orthopedic · 98d
Cleared Apr 18, 2024
Ethylene Oxide Sterilization Supplier Change for MPO Hips
K240046 · LPH
Microport Orthopedics
Orthopedic · 101d
Cleared Apr 18, 2024
Mobility Scooter (C4+)
K234098 · INI
Yongkang Yile Vehicle Co., Ltd.
Physical Medicine · 114d
Cleared Apr 18, 2024
EMBOGUARD Balloon Guide Catheter
K233924 · QJP
Neuravi Limited
Neurology · 127d
Cleared Apr 18, 2024
Difiney Anti Snoring Device
K233850 · LRK
Fissiontech, LLC
Dental · 135d
Cleared Apr 18, 2024
HotDog Warming Mattress + Return Electrode
K232627 · DWJ
Augustine Temperature Management, LLC
Cardiovascular · 233d
Cleared Apr 18, 2024
RAYSCAN a-Expert
K232325 · MUH
Ray Co., Ltd.
Radiology · 259d
Cleared Apr 18, 2024
Prospera Spectruum Negative Pressure Wound Therapy System
K230233 · OMP
Deroyal Industries, Inc.
General & Plastic Surgery · 447d
Cleared Apr 17, 2024
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft...
K240519 · LPL
Innova Vision, Inc.
Ophthalmic · 54d
Cleared Apr 17, 2024
MSFX Mikron Cervical Anterior Plate System
K240484 · KWQ
Mikron Makina Sanayi VE Ticaret Ltd....
Orthopedic · 57d
Cleared Apr 17, 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · EZL
Sentinel Medical Technologies, LLC
Gastroenterology & Urology · 100d
Cleared Apr 17, 2024
Enteral Feeding Sets
K240039 · KNT
Hangzhou Primecare Medical Co., Ltd.
Gastroenterology & Urology · 103d
Cleared Apr 17, 2024
Celerity Chemical Indicator for enspire 3000 CLCSPS
K240032 · JOJ
STERIS Corporation
General Hospital · 104d
Cleared Apr 17, 2024
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET...
K233863 · HRS
TriMed, Inc.
Orthopedic · 133d
Cleared Apr 17, 2024
uOmnispace.MR
K233186 · QIH
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Apr 17, 2024
Goyo Mouthpiece S
K232238 · OBR
Dimedikorea
Dental · 264d
Cleared Apr 17, 2024
Carilex VT¿200-i NX
K231646 · OMP
Carilex Medical, Inc.
General & Plastic Surgery · 317d
Cleared Apr 16, 2024
nextaro® v, 20/20
K240748 · LHI
Sfm Medical Devices GmbH
General Hospital · 28d
Cleared Apr 16, 2024
ReBorn (1050nm)
K233962 · PKT
Lightfective , Ltd.
General & Plastic Surgery · 123d
Cleared Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
K233886 · FDT
Ambu A/S
Gastroenterology & Urology · 130d
Cleared Apr 16, 2024
Alcantara Thoracolumbar Plate System
K232256 · KWQ
Camber Spine Technologies, LLC
Orthopedic · 263d
Cleared Apr 16, 2024
Sectra Digital Pathology Module (Version 3.3)
K232208 · PSY
Sectra AB
Pathology · 265d
Cleared Apr 16, 2024
Aperio GT 450 DX
K232202 · PSY
Leica Biosystems Imaging, Inc.
Pathology · 266d