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
7153–7176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2024
Tulsa Pro System (Pad-105)
K240296 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 98d
Cleared May 09, 2024
Customized Abutment
K234112 · NHA
Arum Dentistry Co., Ltd.
Dental · 134d
Cleared May 09, 2024
CEREGLIDE 92 Catheter System
K233982 · QJP
Cerenovus, Inc.
Neurology · 143d
Cleared May 09, 2024
DePuy Synthes MatrixSTERNUM Fixation System
K233967 · HRS
Synthes GmbH
Orthopedic · 146d
Cleared May 09, 2024
Dental Barrier and Sleeves
K233918 · PEM
Yongqing Huaguan Dental Instruments...
Dental · 148d
Cleared May 09, 2024
P200TE (A10700)
K233602 · OBO
Optos Plc.
Ophthalmic · 182d
Cleared May 09, 2024
Biofourmis Everion+ (G2)
K233418 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 212d
Cleared May 09, 2024
VUZE System
K232976 · LLZ
Vuze Medical , Ltd.
Radiology · 231d
Cleared May 09, 2024
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
K232477 · HGX
Jiangxi AOV Maternity & Baby Products...
Obstetrics & Gynecology · 267d
Cleared May 09, 2024
Polyisoprene Extra Large Condom
K232470 · MOL
Suretex Limited
Obstetrics & Gynecology · 267d
Cleared May 09, 2024
SC Medica FFX
K232468 · MRW
Sc Medica
Orthopedic · 268d
Cleared May 09, 2024
Hushd Pro Avera
K232025 · LRK
Good Sleep CO Pte , Ltd.
Dental · 307d
Cleared May 08, 2024
Tricera Arthroscopic System
K241008 · GEI
Relign Corporation, Subsidiary of...
Orthopedic · 26d
Cleared May 08, 2024
Legend X Applicator VO
K240999 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 27d
Cleared May 08, 2024
FLOW 90? Wand
K240964 · GEI
ArthroCare Corporation
General & Plastic Surgery · 29d
Cleared May 08, 2024
UltraClear Laser System (N/A)
K233803 · GEX
Acclaro Corporation
General & Plastic Surgery · 161d
Cleared May 08, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
K233581 · DHA
Ortho-Clinical Diagnostics
Chemistry · 183d
Cleared May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K232649 · LPL
Pegavision Corporation
Ophthalmic · 251d
Cleared May 08, 2024
F&P myAirvo 3
K222292 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 649d
Cleared May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K240954 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared May 07, 2024
LIFEPAK® ECG Cables
K240377 · DSA
Stryker Physio-Control
Cardiovascular · 90d
Cleared May 07, 2024
AEON Endoscopic Powered Stapler (Short/AEPH060)
K234039 · GAG
Lexington Medical, Inc.
General & Plastic Surgery · 138d
Cleared May 07, 2024
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
K234018 · NHA
Dentsply Sirona
Dental · 139d
Cleared May 07, 2024
ASSURE Wearable ECG
K233864 · MWJ
Kestra Medical Technologies, Inc.
Cardiovascular · 153d