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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12145–12168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2022
ATEC IOM Accessory Instruments
K221821 · PDQ
Alphatec Spine, Inc.
Neurology · 92d
Cleared Sep 23, 2022
Wet Flavored Personal Lubricants
K221829 · NUC
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 92d
Cleared Sep 23, 2022
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
K222152 · JOJ
3M Company
General Hospital · 65d
Cleared Sep 23, 2022
Medical Surgical Mask
K222204 · FXX
Guangzhou Zhengkang Medical Equipment...
General Hospital · 60d
Cleared Sep 23, 2022
Diosculpt
K222265 · PKT
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 57d
Cleared Sep 23, 2022
reepot Nd
K222555 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 31d
Cleared Sep 23, 2022
Align
K222561 · OVD
Acuity Surgical Devices, LLC
Orthopedic · 30d
Cleared Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
K222568 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 23, 2022
FREEPRINT crown
K222877 · EBF
Detax GmbH
Dental · 1d
Cleared Sep 22, 2022
Dual Switch
K211605 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 485d
Cleared Sep 22, 2022
WasherCap Fixation System
K212197 · MBI
Abanza Tecnomed S.L
Orthopedic · 435d
Cleared Sep 22, 2022
CellFX System
K213674 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 304d
Cleared Sep 22, 2022
TRANBERG Thermoguide Therapy System
K214125 · ONO
Clinical Laserthermia Systems, AB
Neurology · 266d
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