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
8041–8064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2023
xeo+ Family
K233237 · GEX
Cutera, Inc.
General & Plastic Surgery · 78d
Cleared Dec 15, 2023
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
K233182 · LZA
Zibo Kaiyue Mould Technology Co., Ltd.
General Hospital · 78d
Cleared Dec 15, 2023
Sterile and Non-Sterile Ultrasound Gels
K232957 · MUI
Jianerkang Medical Co., Ltd.
Radiology · 85d
Cleared Dec 15, 2023
IPL Hair Removal Device
K232939 · OHT
Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 15, 2023
Hp Detect™ Stool Antigen ELISA
K232892 · LYR
Biomerica, Inc.
Microbiology · 88d
Cleared Dec 15, 2023
Invisalign Palatal Expander System
K232887 · NXC
Align Technology, Inc.
Dental · 88d
Cleared Dec 15, 2023
Unscented Menstrual Tampon
K232598 · HEB
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared Dec 15, 2023
Internal Locking Plate and Screw Fixation System
K232394 · HRS
Changzhou Geasure Medical Apparatus...
Orthopedic · 128d
Cleared Dec 15, 2023
Videa Dental Assist
K232384 · MYN
Videahealth, Inc.
Radiology · 129d
Cleared Dec 15, 2023
Precice Max System
K232267 · HSB
Nuvasive Specialized Orthopedics,...
Orthopedic · 137d
Cleared Dec 15, 2023
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
K232130 · OWQ
Surgical Instrument Services and...
Cardiovascular · 151d
Cleared Dec 15, 2023
SeptiCyte RAPID
K232095 · PRE
Immunexpress, Inc.
Microbiology · 155d
Cleared Dec 15, 2023
Panther TPS
K231825 · MUJ
Prowess, Inc.
Radiology · 177d
Cleared Dec 15, 2023
Ziehm Vision FD
K231700 · OWB
Ziehm Imaging GmbH
Radiology · 186d
Cleared Dec 15, 2023
Digital Blood Pressure Monitor (Model: YB-800)
K231478 · DXN
Wenzhou Yosun Medical Technology Co.,Ltd
Cardiovascular · 207d
Cleared Dec 15, 2023
Double Internal Joint Stabilizer- Elbow
K231447 · OZI
Skeletal Dynamics, Inc.
Orthopedic · 211d
Cleared Dec 15, 2023
Cardio Q50, Cardio Q70
K231160 · DPS
Bionet Co., Ltd.
Cardiovascular · 238d
Cleared Dec 15, 2023
ARTIS pheno (VE30A)
K230949 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 255d
Cleared Dec 15, 2023
Ova+ (K-OVAP-USA)
K230926 · NUH
Tenscare, Ltd.
Neurology · 256d
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Dec 15, 2023
Spirobank Oxi
K230501 · BZG
Mir Medical International Research USA
Anesthesiology · 294d
Cleared Dec 15, 2023
Masimo Stork
K223721 · DQA
Masimo Corporation
Anesthesiology · 368d
Cleared Dec 14, 2023
Ascension Silicone MCP
K233670 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 29d
Cleared Dec 14, 2023
Millipede 088 Access Catheter
K233648 · QJP
Perfuze, Ltd.
Neurology · 30d