FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14041–14064 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2022
Air compression leg massager HY-1117A
K212713 · IRP
Xiamen High Top Electronic Technology...
Physical Medicine · 145d
Cleared Jan 18, 2022
Microvolume Luer Access Device
K212842 · FPA
B.Braun Medical, Inc.
General Hospital · 133d
Cleared Jan 18, 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K213216 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 111d
Cleared Jan 18, 2022
JuniOrtho Plating System™
K213572 · HWC
Orthofix Srl
Orthopedic · 69d
Cleared Jan 18, 2022
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
K213781 · MBH
Depuy Ireland UC
Orthopedic · 46d
Cleared Jan 17, 2022
Medical Face Mask
K212994 · FXX
Guangzhou Quantum Laser Intelligent...
General Hospital · 119d
Cleared Jan 16, 2022
Disposable Medical Face Mask
K211833 · FXX
Zhejiang the Purples Protective...
General Hospital · 216d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d
Cleared Jan 16, 2022
Kangbeier Surgical Mask (Model: KBR-1001)
K213920 · FXX
Xinxiang Kangbeier Medical Technology...
General Hospital · 32d
Cleared Jan 15, 2022
Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
K211360 · LZA
Pt. Universal Gloves
General Hospital · 257d
Cleared Jan 15, 2022
Precision Align
K212772 · NXC
Precision Align, LLC
Dental · 137d
Cleared Jan 14, 2022
Bio-Medicus Life Support Catheter and Introducer
K201057 · QHW
Medtronic, Inc.
Cardiovascular · 633d
Cleared Jan 14, 2022
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film...
K202783 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 479d
Cleared Jan 14, 2022
BRM TOOL Screws
K203773 · HWC
Brm Extremities Srl
Orthopedic · 387d
Cleared Jan 14, 2022
Silver Gelling Fiber Dressing
K210466 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 332d
Cleared Jan 14, 2022
Precise Image
K210760 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 305d
Cleared Jan 14, 2022
ARAI Surgical Navigation System
K211254 · SBF
Surgalign Spine Technologies
Orthopedic · 263d
Cleared Jan 14, 2022
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100,...
K211632 · DQA
Shenzhen Narig Bio-Medical Technology...
Anesthesiology · 232d
Cleared Jan 14, 2022
Wellead Endoscopic Seal
K211814 · ODC
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Jan 14, 2022
Medline Universal Grounding Pad
K212093 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 192d
Cleared Jan 14, 2022
IPL Hair Removal
K212318 · OHT
Dongguan Define Beauty Electronic...
General & Plastic Surgery · 172d
Cleared Jan 14, 2022
Dermatological diode laser system
K212478 · GEX
Beijing Stelle Laser Technology Co.,...
General & Plastic Surgery · 158d
Cleared Jan 14, 2022
Surgical Face Mask
K212913 · FXX
Jiangxi Ganlong Pharmaceutical Co., Ltd.
General Hospital · 123d
Cleared Jan 14, 2022
Surgical Mask
K212997 · FXX
Guangdong Zhizhen Biological Medical...
General Hospital · 116d