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
9769–9792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2023
Voluson SWIFT
K230346 · IYN
Ge Medical Systems Ultrasound &...
Radiology · 132d
Cleared Jun 20, 2023
SMARTbase Abutment System
K223535 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 209d
Cleared Jun 20, 2023
NC° Thermometer (Gen 3), Model Number: NCTG3
K223522 · FLL
Xiamen Intretech, Inc.
General Hospital · 209d
Cleared Jun 20, 2023
BethaLoc® stem cementless HA
K223103 · LZO
Implantcast GmbH
Orthopedic · 263d
Cleared Jun 20, 2023
Perfit CL
K223029 · EIH
Vatech Mcis Co., Ltd.
Dental · 264d
Cleared Jun 20, 2023
F3
K222998 · OWB
Acrew Imaging, Inc.
Radiology · 265d
Cleared Jun 20, 2023
tremoflo C2 Airwave Oscillometry System
K221024 · PNV
Thorasys Thoracic Medical Systems, Inc.
Anesthesiology · 440d
Cleared Jun 18, 2023
Sinobot X1
K220072 · HAW
Sinovation (Beijing) Medical...
Neurology · 524d
Cleared Jun 17, 2023
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7,...
K223920 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 170d
Cleared Jun 17, 2023
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P,...
K223917 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 170d
Cleared Jun 16, 2023
Smart Correction System (HA Half Pins)
K231461 · KTT
Wishbone Medical, Inc.
Orthopedic · 28d
Cleared Jun 16, 2023
Solar Lumbar Interbody Fusion System
K231199 · MAX
Degen Medical
Orthopedic · 50d
Cleared Jun 16, 2023
Fitness Belt (Model: KLT-07)
K231136 · NGX
Shenzhen Kelutongda Industrial Co., Ltd.
Physical Medicine · 56d
Cleared Jun 16, 2023
Manual Wheelchair (A006)
K231110 · IOR
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine · 58d
Cleared Jun 16, 2023
Healgen URS Test Strips
K231045 · LJX
Healgen Scientific, LLC
Chemistry · 65d
Cleared Jun 16, 2023
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A)...
K230965 · HQD
Acuity Polymers, Inc.
Ophthalmic · 72d
Cleared Jun 16, 2023
NewVision SC (tisilfocon A) Scleral Lens
K230910 · HQD
Acculens, Inc.
Ophthalmic · 77d
Cleared Jun 16, 2023
NuVasive Modulus ALIF System
K230894 · OVD
Nu Vasive, Incorporated
Orthopedic · 77d
Cleared Jun 16, 2023
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
K230538 · QUH
Sonova AG
Ear, Nose, Throat · 109d
Cleared Jun 16, 2023
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines...
K230514 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 112d
Cleared Jun 16, 2023
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM...
K230421 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 120d
Cleared Jun 16, 2023
OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit...
K230015 · KNW
Laurane Medical Sas
General & Plastic Surgery · 164d
Cleared Jun 16, 2023
NAJA Gastrointestinal Catheter
K223890 · FGD
Chess Medical, Inc.
Gastroenterology & Urology · 171d
Cleared Jun 16, 2023
IB Lab LAMA
K223646 · QIH
Ib Lab GmbH
Radiology · 192d