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
28633–28656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2017
Surgi Max Ultra
K170107 · GEI
Elliquence, LLC
General & Plastic Surgery · 111d
Cleared May 03, 2017
Hee HR Mini
K170269 · OHT
Oriental Inspiration Limited
General & Plastic Surgery · 96d
Cleared May 03, 2017
KISSloc Suture System
K170440 · HTN
Arthrosurface, Inc.
Orthopedic · 78d
Cleared May 03, 2017
Iridex TruFocus LIO Premiere
K170718 · GEX
Iridex Corporation
General & Plastic Surgery · 55d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 03, 2017
Silhouette Featherlift
K171005 · GAW
Silhouette Lift, Inc.
General & Plastic Surgery · 29d
Cleared May 02, 2017
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
K160781 · KGO
Semperit Investments Asia Pte , Ltd.
General Hospital · 406d
Cleared May 02, 2017
iGlucose Blood Glucose Monitoring System
K161790 · NBW
Bionime Corporation
Chemistry · 307d
Cleared May 02, 2017
Airworks Nebulizer pe1200m
K162041 · CAF
Convexity Scientific, LLC
Anesthesiology · 281d
Cleared May 02, 2017
Locking Plate System
K162380 · HRS
Beijing Keyi Medical Device...
Orthopedic · 251d
Cleared May 02, 2017
Vitoss Bioactive (BA) Injectable
K163621 · MQV
Orthovita, Inc.
Orthopedic · 131d
Cleared May 02, 2017
ARIES Bordetella Assay
K163626 · OZZ
Luminex Corporation
Microbiology · 131d
Cleared May 02, 2017
AssureTech Panel Dip Test, AssureTech Quick Cup Test
K170049 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 117d
Cleared May 02, 2017
Xultan 5.5 Pedicle Screw System
K170108 · NKB
Met One Technologies
Orthopedic · 110d
Cleared May 02, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable...
K170141 · GZB
Stimwave Technologies Incorporated
Neurology · 105d
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · PCH
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 02, 2017
NAVIO
K170360 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 85d
Cleared May 02, 2017
Collagen Meniscus Implant XL
K170364 · OLC
Ivy Sports Medicine, LLC
Orthopedic · 85d
Cleared May 02, 2017
AXIS Image Management System
K171098 · NFJ
Sonomed, Inc.
Ophthalmic · 19d
Cleared May 01, 2017
The Cranial Fusion System
K162266 · NKG
Life Spine, Inc.
Orthopedic · 263d
Cleared May 01, 2017
REDAPT Sleeved Monolithic Revision Stems
K162303 · MEH
Smith & Nephew, Inc.
Orthopedic · 257d
Cleared May 01, 2017
Remel Spectra ESBL
K162620 · JSO
Remel, Inc.
Microbiology · 223d
Cleared May 01, 2017
NuVasive NuvaLine Mobile App
K162647 · LLZ
Nu Vasive, Incorporated
Radiology · 221d
Cleared May 01, 2017
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
K162751 · NUJ
Surgical Instrument Services and...
General & Plastic Surgery · 213d