FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7057–7080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2024
ulricheasyINJECT Max 2M (XD 10140)
K233737 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 149d
Cleared Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
K233373 · QYT
ACON Laboratories, Inc.
Microbiology · 200d
Cleared Apr 19, 2024
AccuCath Ace™ Intravascular Catheter
K233106 · FOZ
Bard Access Systems, Inc. (C.R. Bard,...
General Hospital · 205d
Cleared Apr 19, 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · GZJ
Oriental Inspiration Limited
Neurology · 207d
Cleared Apr 19, 2024
Patient Monitor (iX10, iX12, iX15)
K232962 · MHX
Edan Instruments, Inc.
Cardiovascular · 211d
Cleared Apr 19, 2024
NewPort Spinal System
K232566 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 239d
Cleared Apr 19, 2024
Healgen Rapid COVID-19 Antigen Test
K232377 · QVF
Healgen Scientific, LLC
Microbiology · 255d
Cleared Apr 19, 2024
Patriot-SI Posterior Implant System
K232259 · OUR
Spinal Simplicity, LLC
Orthopedic · 263d
Cleared Apr 19, 2024
Hemoblock_S (Prescription)
K232216 · QSY
Incore Co., Ltd.
General & Plastic Surgery · 268d
Cleared Apr 19, 2024
ReyaGel (RG03 - MTP gel 3mL)
K232204 · KGN
Fettech
General & Plastic Surgery · 269d
Cleared Apr 19, 2024
APTUS Foot System 2.8-3.5
K232105 · HRS
Medartis AG
Orthopedic · 280d
Cleared Apr 19, 2024
KeYi Total Knee System
K230120 · JWH
Beijing Keyi Medical Device...
Orthopedic · 458d
Cleared Apr 18, 2024
Disposable Medical Face Mask (M643BE)
K240258 · FXX
Makrite Industries, Inc.
General Hospital · 78d
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