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
11641–11664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2022
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)
K223472 · DRE
Spectranetics, Inc.
Cardiovascular · 28d
Cleared Dec 14, 2022
ICE Ceramics, ICE Stains, Fresco
K213722 · EIH
Zirkonzahn Srl
Dental · 383d
Cleared Dec 14, 2022
Magicore Narrow System
K220079 · DZE
Innobiosurg Co., Ltd.
Dental · 338d
Cleared Dec 14, 2022
QuikClot Control+ Hemostatic Dressing
K220971 · POD
Z-Medica, LLC
General & Plastic Surgery · 254d
Cleared Dec 14, 2022
PTA Balloon Dilatation Catheter
K221245 · LIT
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 226d
Cleared Dec 14, 2022
Infrared Thermometer (Model: Y20001, Y20002)
K221800 · FLL
Zhangzhou Easepal Medical Science and...
General Hospital · 176d
Cleared Dec 14, 2022
UNO Negative Pressure Wound Therapy System
K221891 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 168d
Cleared Dec 14, 2022
QRS Dental Implants System
K221910 · DZE
Qrs Medical , Ltd.
Dental · 167d
Cleared Dec 14, 2022
Nitrile Patient Examination Glove
K222527 · LZA
Pingan Medical Products Co., Ltd.
General Hospital · 114d
Cleared Dec 14, 2022
Target Tetra Detachable Coils
K222533 · HCG
Stryker Neurovascular
Neurology · 114d
Cleared Dec 14, 2022
Digital Crown
K222623 · EBF
Sprintray, Inc.
Dental · 105d
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