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
6673–6696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2024
ViewPoint 6
K241300 · LLZ
Ge Healthcare GmbH
Radiology · 54d
Cleared Jul 02, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55...
K240930 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 89d
Cleared Jul 02, 2024
ZIEN IO Intraosseous Access System
K240915 · FMI
Zien Medical Technologies, Inc.
General Hospital · 90d
Cleared Jul 02, 2024
Freedom® Total Knee System
K240863 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 96d
Cleared Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jul 02, 2024
Ultrasonic Scaler...
K240707 · ELC
Shenzhen Micro Electric Intelligence...
Dental · 109d
Cleared Jul 02, 2024
Tyto Insights for Crackles Detection
K240555 · PHZ
Tyto Care , Ltd.
Anesthesiology · 125d
Cleared Jul 02, 2024
Next Generation Aspiration Catheter
K234083 · NRY
Balt USA, LLC
Neurology · 193d
Cleared Jul 02, 2024
Next Generation Access Catheter
K234074 · QJP
Balt USA, LLC
Neurology · 193d
Cleared Jul 02, 2024
AOS Marker Seeds (SMG0242-025)
K233626 · JAQ
Alpha-Omega Services, Inc.
Radiology · 232d
Cleared Jul 02, 2024
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal...
K233440 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 258d
Cleared Jul 02, 2024
DELTAWAVE Nasal Pillows System
K233415 · BZD
Remsleep Holdings
Anesthesiology · 266d
Cleared Jul 02, 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*...
K232824 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 293d
Cleared Jul 01, 2024
Single-use Video Ureterorenoscope (SVU-220US)
K241639 · FGB
Huger Medical Instrument Co., Ltd.
Gastroenterology & Urology · 24d
Cleared Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
K241598 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Jul 01, 2024
Electric nasal aspirator (HTD2601US)
K241202 · BTA
Hetaida Technology Co., Ltd.
Ear, Nose, Throat · 62d
Cleared Jul 01, 2024
BioSonic US200 Ultrasonic Scaler (60034537)
K240801 · ELC
Dent4you AG
Dental · 98d
Cleared Jul 01, 2024
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m)...
K240572 · GEI
Covidien, LLC
General & Plastic Surgery · 123d
Cleared Jul 01, 2024
Wearable Breast Pump (Model S32)
K240536 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 126d
Cleared Jul 01, 2024
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K240477 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 132d
Cleared Jul 01, 2024
Hyper Insight - ICH
K240353 · QAS
Sk, Inc.
Radiology · 147d
Cleared Jul 01, 2024
SPECTRALIS HRA+OCT and variants
K240221 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 157d
Cleared Jul 01, 2024
Profound Matrix
K240070 · GEI
Candela Corporation
General & Plastic Surgery · 174d
Cleared Jul 01, 2024
StarFormer
K234061 · KPI
Fotona D.O.O.
Gastroenterology & Urology · 192d