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
6697–6720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2024
cNeuro cDAT
K233908 · LLZ
Combinostics OY
Radiology · 202d
Cleared Jul 01, 2024
Cryo-straw (Type I, Type III)
K233477 · MQL
Shandong Wego Ruisheng Medical Device...
Obstetrics & Gynecology · 249d
Cleared Jul 01, 2024
Pulse Oximeter (AOJ-70A)
K232989 · DQA
Shenzhen AOJ Medical Technology Co.,...
Anesthesiology · 283d
Cleared Jul 01, 2024
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,...
K232777 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 294d
Cleared Jul 01, 2024
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
K231015 · NLI
Innovative Health, LLC
Cardiovascular · 448d
Cleared Jun 28, 2024
nordicMEDiVA
K241608 · LLZ
Nordicneurolab AS
Radiology · 24d
Cleared Jun 28, 2024
NUVISION™ Ultrasound Catheter
K241540 · OBJ
Biosense Webster, Inc.
Cardiovascular · 28d
Cleared Jun 28, 2024
Lavieen
K241406 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 42d
Cleared Jun 28, 2024
Hello,eyes® BIO Plug
K241229 · LZU
Bio Optics Co., Ltd.
Ophthalmic · 57d
Cleared Jun 28, 2024
TopCEM-Veneer Light Cure Veneer Cement
K241204 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 59d
Cleared Jun 28, 2024
Electric Wheelchair (YFWB-63)
K241154 · ITI
If Health (Xiamen) Intelligent...
Physical Medicine · 63d
Cleared Jun 28, 2024
Access Thyroglobulin
K240927 · MSW
Beckman Coulter, Inc.
Immunology · 85d
Cleared Jun 28, 2024
ARTFX MEDICAL Cervical PEEK Cages
K240893 · ODP
Artfx Medical
Orthopedic · 88d
Cleared Jun 28, 2024
XSense Cryoablation System with Cryoprobes
K240892 · GEH
IceCure Medical , Ltd.
General & Plastic Surgery · 88d
Cleared Jun 28, 2024
Patient Monitor (RespArray)
K240320 · MHX
Edan Instruments, Inc.
Cardiovascular · 147d
Cleared Jun 28, 2024
BLUE 400
K240215 · QFX
Carl Zeiss Meditec, AG
Neurology · 154d
Cleared Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
K240164 · FIB
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 158d
Cleared Jun 28, 2024
Ultrasonic Fetal Doppler
K233823 · KNG
Shenzhen Jamr Technology Co., Ltd.
Obstetrics & Gynecology · 210d
Cleared Jun 28, 2024
Cordis BRITECROSS Support Catheter
K233637 · DQY
Cordis US Corp
Cardiovascular · 228d
Cleared Jun 28, 2024
Magseed Pro Magnetic Marker System
K232865 · NEU
Endomagnetics Ltd.,
General & Plastic Surgery · 287d
Cleared Jun 27, 2024
Auryon Atherectomy Catheter 1.7mm
K241553 · MCW
Eximo Medical, Ltd.
Cardiovascular · 27d
Cleared Jun 27, 2024
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack...
K241542 · FRC
3M Company
General Hospital · 27d
Cleared Jun 27, 2024
Mojo 2 Full Face Non-Vented Mask
K241520 · CBK
Sleepnet Corporation
Anesthesiology · 29d
Cleared Jun 27, 2024
TENS&EMS units (SM9109A, SM9109B)
K241509 · NUH
Plexus Yoga, LLC Dba Chirp
Neurology · 30d