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
15385–15408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2021
CoreLink Navigation Instruments
K212825 · OLO
Corelink, LLC
Orthopedic · 40d
Cleared Oct 13, 2021
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
K212908 · NRY
Neuravi, Ltd.
Neurology · 30d
Cleared Oct 12, 2021
Disposable Surgical Mask (Model: YYKZ-01)
K210845 · FXX
Jiaxing Amazing Travel-Ware Co., Ltd.
General Hospital · 204d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 112d
Cleared Oct 12, 2021
VBrain-OAR
K212116 · QKB
Vysioneer, Inc.
Radiology · 97d
Cleared Oct 12, 2021
BC Reflex Uni Knee System
K212307 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 81d
Cleared Oct 12, 2021
Correx Software
K212552 · KTT
Vilex, LLC
Orthopedic · 60d
Cleared Oct 12, 2021
Signature™ ONE System
K212560 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 60d
Cleared Oct 12, 2021
Idys-C ZP 3DTi
K212562 · OVE
Clariance, SA
Orthopedic · 60d
Cleared Oct 10, 2021
Child Face Mask
K201514 · OXZ
Shandong Shengquan New Material Co.,...
General Hospital · 489d
Cleared Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
K203750 · NHA
Institut Straumann AG
Dental · 290d
Cleared Oct 09, 2021
STERRAD 100NX Sterilizer with ALLClear Technology
K212174 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 89d
Cleared Oct 08, 2021
The Micro Screw System, Micro Screw System Basic
K201210 · DZL
Hager& Meisinger GmbH
Dental · 521d
Cleared Oct 08, 2021
B4C System
K201989 · GWM
Braincare Desenvolvimento E Inovacao...
Neurology · 448d
Cleared Oct 08, 2021
Infrared Thermometer (Model K9)
K203497 · FLL
Kangzhan Communication Electronics...
General Hospital · 315d
Cleared Oct 08, 2021
Clear Aligner
K203688 · NXC
Wuxi EA Medical Instruments...
Dental · 295d
Cleared Oct 08, 2021
INTEGRA Wound Matrix (Macro-Channels)
K210128 · KGN
Integra LifeSciences Corporation
General & Plastic Surgery · 262d
Cleared Oct 08, 2021
PuraStat-OM
K210211 · OLR
3-D Matrix, Inc.
General & Plastic Surgery · 254d
Cleared Oct 08, 2021
Single-Use Medical Face Mask
K210622 · FXX
Jiangxi Hongda Medical Equipment...
General Hospital · 220d
Cleared Oct 08, 2021
Medical Surgical Mask
K210813 · FXX
Sichuan Pharmaceutical., Inc.
General Hospital · 205d
Cleared Oct 08, 2021
Streamline Surgical System
K211680 · MRH
New World Medical, Inc.
Ophthalmic · 129d
Cleared Oct 08, 2021
Esophageal TTS Stent
K211706 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 127d
Cleared Oct 08, 2021
Medical Examination Gloves
K212078 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 98d
Cleared Oct 08, 2021
ABCcolla Bone Matrix
K212156 · MQV
Acro Biomedical Co., Ltd.
Orthopedic · 88d