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
11377–11400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2022
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx,...
K212071 · PCC
Cefaly Technology
Neurology · 529d
Cleared Dec 13, 2022
Epilaser Absolute
K213105 · GEX
Epilady 2000, LLC
General & Plastic Surgery · 445d
Cleared Dec 13, 2022
CCBIO ASCPO Needle
K214004 · FMI
Cc Biotechnology Corporation
General Hospital · 357d
Cleared Dec 13, 2022
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer...
K220046 · DJG
Shenzhen Superbio Technology Co., Ltd.
Toxicology · 342d
Cleared Dec 13, 2022
HVT 2.0
K221318 · QAV
Vapotherm, Inc.
Anesthesiology · 221d
Cleared Dec 13, 2022
REDEMPTION Beaming System
K221342 · HWC
Vilex, LLC
Orthopedic · 218d
Cleared Dec 13, 2022
Surgical Face Mask
K222651 · FXX
Xiantao Sanda Industrial Co., Ltd.
General Hospital · 103d
Cleared Dec 13, 2022
Conductive Gel
K222770 · GYB
Top-Rank Health Care Co., Ltd.
Neurology · 90d
Cleared Dec 13, 2022
Quantra QPlus System
K223433 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Dec 12, 2022
Medidenta High Speed Handpieces
K202674 · EFB
Pac-Dent, Inc.
Dental · 818d
Cleared Dec 12, 2022
BioButton System
K212957 · DRG
Biolntellisense, Inc.
Cardiovascular · 452d
Cleared Dec 12, 2022
Metal Bone Screw
K220921 · HWC
Double Medical Technology, Inc.
Orthopedic · 257d
Cleared Dec 12, 2022
Spectra Wearable
K220926 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 256d
Cleared Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · LTK
Ortho-Clinical Diagnostics
Immunology · 216d
Cleared Dec 12, 2022
SIRIUS Endoscope System
K221642 · HET
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery · 189d
Cleared Dec 12, 2022
Hive™ Standalone Cervical System
K223190 · OVE
NanoHive Medical, LLC
Orthopedic · 60d
Cleared Dec 12, 2022
Matrix HA Fusion Porous Cervical IBF System
K223510 · ODP
Innovasis, Inc.
Orthopedic · 20d
Cleared Dec 11, 2022
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
K222733 · LZA
Inner Mongolia Boming Medical...
General Hospital · 93d
Cleared Dec 09, 2022
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · FMF
Medline Industries, Inc.
General Hospital · 443d
Cleared Dec 09, 2022
RobPath® Total Hip Application
K220774 · OLO
Hangzhou Lancet Robotics Co., Ltd.
Orthopedic · 268d
Cleared Dec 09, 2022
3D-SHAPER
K220822 · KGI
3D-Shaper Medical S.L
Radiology · 263d
Cleared Dec 09, 2022
PMT Facet Fixation System (PMT FFS)
K220951 · MRW
Providence Medical Technology, Inc.
Orthopedic · 252d
Cleared Dec 09, 2022
Vesseal
K221280 · GAW
Lydus Medical , Ltd.
General & Plastic Surgery · 220d
Cleared Dec 09, 2022
Wearable breast pump
K221598 · HGX
Mayborn (Uk) Limited
Obstetrics & Gynecology · 190d