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
11881–11904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2022
Supra Non-Stick Bipolar Forceps
K213042 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 421d
Cleared Nov 17, 2022
C.C. LIFE 21
K213295 · PBX
21 Equipment S.R.L.
General & Plastic Surgery · 412d
Cleared Nov 17, 2022
Dentca Base Premium, Dentca Base Hi-Impact
K220042 · EBI
Dentca, Inc.
Dental · 316d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Nov 17, 2022
Disposable Urine Collection Tube
K220739 · JSM
Zhejiang Gongdong Medical Technology...
Microbiology · 248d
Cleared Nov 17, 2022
Parky App
K220820 · GYD
H2o Bilisim Yazilim
Neurology · 241d
Cleared Nov 17, 2022
xvision Spine System
K220905 · SBF
Augmedics, Ltd.
Orthopedic · 234d
Cleared Nov 17, 2022
Disposable Insulin Pen Needle
K221178 · FMI
Ningbo Medsun Medical Co., Ltd.
General Hospital · 206d
Cleared Nov 17, 2022
Multitom Rax
K221281 · OWB
Siemens Medical Solutions
Radiology · 198d
Cleared Nov 17, 2022
Persona Personalized Knee System
K221479 · JWH
Zimmer, Inc.
Orthopedic · 178d
Cleared Nov 17, 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
K221593 · EZD
Convatec, Inc.
Gastroenterology & Urology · 168d
Cleared Nov 17, 2022
Accure Laser
K222109 · GEX
Accure Acne, Inc.
General & Plastic Surgery · 122d
Cleared Nov 17, 2022
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
K222208 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 115d
Cleared Nov 17, 2022
OmegaAI Image Viewer
K222476 · LLZ
Ramsoft, Inc.
Radiology · 93d
Cleared Nov 17, 2022
FX Contra
K222518 · EGS
Nakanishi, Inc.
Dental · 90d
Cleared Nov 17, 2022
IPL Hair Removal Device
K222598 · OHT
Shenzhen Noble Smart Manufacturing...
General & Plastic Surgery · 80d
Cleared Nov 17, 2022
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
K222673 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 72d
Cleared Nov 17, 2022
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti...
K222973 · ODP
Alphatec Spine, Inc.
Orthopedic · 50d
Cleared Nov 17, 2022
MAVEN™ Patient-Specific Instrumentation
K223227 · HSN
Paragon 28, Inc.
Orthopedic · 30d
Cleared Nov 17, 2022
SKR 3000
K223267 · MQB
Konica Minolta, Inc.
Radiology · 24d
Cleared Nov 17, 2022
easy Claire
K223278 · OHS
Y & J Bio Co., Ltd.
General & Plastic Surgery · 24d
Cleared Nov 16, 2022
KNH Surgical Face Mask
K203528 · FXX
Knh Surgical Face Mask
General Hospital · 714d
Cleared Nov 16, 2022
Surgical Gown
K212812 · FYA
Xianning Marveldas Protective...
General Hospital · 439d
Cleared Nov 16, 2022
Disposable surgical face mask
K220302 · FXX
Shandong Aida Medical Products Co., Ltd.
General Hospital · 287d