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
12433–12456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2022
Disposable Polyp Snare
K220089 · FDI
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 254d
Cleared Sep 22, 2022
ProGrip Self-Gripping Polypropylene Mesh
K220540 · FTL
Covidien
General & Plastic Surgery · 209d
Cleared Sep 22, 2022
Talee, Talee PostOP
K220681 · MVA
Invent Medical USA, LLC
Neurology · 198d
Cleared Sep 22, 2022
SurgiLance® Safety Lancet
K222224 · FMK
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 59d
Cleared Sep 22, 2022
GlasIonomer FX ULTRA
K222253 · EMA
Shofu Dental Corporation
Dental · 57d
Cleared Sep 22, 2022
Irrisept Antimicrobial Wound Lavage
K222804 · FQH
Irrimax Corporation
General & Plastic Surgery · 6d
Cleared Sep 21, 2022
EQ-M
K210475 · EKX
Meta Systems Co., Ltd.
Dental · 581d
Cleared Sep 21, 2022
PWD Negative Pressure Wound Therapy System
K212359 · OMP
Applied Tissue Technologies, LLC
General & Plastic Surgery · 419d
Cleared Sep 21, 2022
EpiFaith CV
K212615 · DQX
Flat Medical Co., Ltd.
Cardiovascular · 399d
Cleared Sep 21, 2022
Clearblue ® Early Pregnancy Test
K213379 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 343d
Cleared Sep 21, 2022
V-Print dentbase
K220236 · EBI
Voco GmbH
Dental · 237d
Cleared Sep 21, 2022
BD MAX Enteric Viral Panel
K220607 · PCH
Becton, Dickinson and Company
Microbiology · 203d
Cleared Sep 21, 2022
SomnoMetry
K221179 · OLZ
Neumetry Medical, Inc.
Neurology · 149d
Cleared Sep 21, 2022
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608,...
K221214 · ONF
Shenzhen Ionka Medical Technology...
General & Plastic Surgery · 147d
Cleared Sep 21, 2022
MedtFine Blood Lancet
K221383 · QRK
Shanghai Carelife International...
General & Plastic Surgery · 131d
Cleared Sep 21, 2022
SpeediCath Flex Set
K222059 · EZD
Coloplast
Gastroenterology & Urology · 70d
Cleared Sep 21, 2022
ArcSP Suprapubic Sling System
K222293 · OTN
Urocure, LLC
Gastroenterology & Urology · 51d
Cleared Sep 21, 2022
MCB UNIT Model: V10GMCBUS
K222542 · KNS
Lamidey Noury Medical
Gastroenterology & Urology · 30d
Cleared Sep 20, 2022
Aorta-CAD
K213353 · MYN
Imagen Technologies, Inc.
Radiology · 347d
Cleared Sep 20, 2022
LUOFUCON Collagen Wound Dressing
K213598 · KGN
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 309d
Cleared Sep 20, 2022
Millipede 088 Access Catheter
K214048 · QJP
Perfuze, Ltd.
Neurology · 267d
Cleared Sep 20, 2022
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
K214056 · LZA
Mezorrison Medical Technology...
General Hospital · 267d
Cleared Sep 20, 2022
Tandry Compression Screw System
K220359 · HWC
Microware Precision Co., Ltd.
Orthopedic · 224d
Cleared Sep 20, 2022
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
K221227 · FLE
Tuttnauer , Ltd.
General Hospital · 145d