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
3361–3384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2025
Integrity™ Implant
K250997 · OWX
Anika Therapeutics, Inc.
Orthopedic · 77d
Cleared Jun 17, 2025
SKR 3000
K250665 · MQB
Konica Minolta, Inc.
Radiology · 104d
Cleared Jun 17, 2025
RT Elements (4.5)
K250440 · MUJ
Brainlab AG
Radiology · 123d
Cleared Jun 17, 2025
Dorado™ PTA Balloon Dilatation Catheter
K250219 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 17, 2025
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990,...
K243880 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 181d
Cleared Jun 17, 2025
uOmniscan
K243666 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Jun 17, 2025
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
K243618 · KDN
Bridge TO Life
Gastroenterology & Urology · 207d
Cleared Jun 17, 2025
Nano-Check Influenza+COVID-19 Dual Test
K243561 · SCA
Nano-Ditech Corporation
Microbiology · 211d
Cleared Jun 17, 2025
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested...
K243133 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 260d
Cleared Jun 17, 2025
VitalSigns 1-Lead Holter (VSH101)
K243003 · DXH
VitalSigns Technology Co., Ltd.
Cardiovascular · 264d
Cleared Jun 16, 2025
X-PAC® TLIF Expandable Posterior Cage System
K251617 · MAX
Expanding Innovations, Inc.
Orthopedic · 20d
Cleared Jun 16, 2025
EvoEndo Single-Use Endoscopy System
K250900 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 16, 2025
Methinks NCCT Stroke
K250685 · QAS
Methinks Software, S.L
Radiology · 102d
Cleared Jun 16, 2025
MAGNETOM Avanto Fit
K250443 · LNH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jun 16, 2025
MAGNETOM Flow.Ace
K250436 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 122d
Cleared Jun 16, 2025
Mosaic (V1.0.1)
K244012 · LLZ
Navier Medical
Radiology · 172d
Cleared Jun 16, 2025
BD Veritor System for SARS-CoV-2
K243872 · QVF
Becton, Dickinson and Company
Microbiology · 181d
Cleared Jun 16, 2025
Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · EZL
Guangdong Ecan Medical Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Jun 16, 2025
Geo Abutment
K242978 · NHA
Geomedi Co,., Ltd.
Dental · 263d
Cleared Jun 16, 2025
Access hsTnI
K242870 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Jun 15, 2025
IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05,...
K243036 · OHT
Bestway Plastic and Metal Products ,...
General & Plastic Surgery · 261d
Cleared Jun 15, 2025
Bioptimal Bipolar Pacing Catheter
K242863 · LDF
Bioptimal International Pte. , Ltd.
Cardiovascular · 268d
Cleared Jun 15, 2025
Withings ECG App
K240795 · QDA
Withings
Cardiovascular · 450d
Cleared Jun 13, 2025
Excipio LV Prime Thrombectomy Device
K251485 · QEW
Contego Medical, Inc.
Cardiovascular · 30d