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
11353–11376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2022
Hexanium PLIF
K223251 · MAX
Spinevision, S.A.S.
Orthopedic · 56d
Cleared Dec 16, 2022
BrainInsight
K223268 · QIH
Hyperfine, Inc.
Radiology · 53d
Cleared Dec 16, 2022
Sterile Hypodermic Needles for Single Use
K223334 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 45d
Cleared Dec 15, 2022
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright...
K214086 · ELW
Genoss Co., Ltd.
Dental · 353d
Cleared Dec 15, 2022
PM Excellence SEQUR 100 Surgical Face Mask
K220520 · FXX
Pm Excellence, LLC
General Hospital · 295d
Cleared Dec 15, 2022
Proxima
K220591 · NFB
Dynasthetics, LLC
Anesthesiology · 289d
Cleared Dec 15, 2022
Perceptive electric dental motor and control unit
K220873 · EIA
Lares Research
Dental · 265d
Cleared Dec 15, 2022
Small Field Applicator
K220883 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 265d
Cleared Dec 15, 2022
LOTUS Series 4 Enhanced Shears, LOTUS Series 5
K221102 · LFL
Sra Developments, Ltd.
General & Plastic Surgery · 245d
Cleared Dec 15, 2022
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
K221267 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 227d
Cleared Dec 15, 2022
S.I.N. Dental Implant System
K221453 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 210d
Cleared Dec 15, 2022
Dozee VS
K221555 · BZQ
Turtle Shell Technologies Private...
Anesthesiology · 198d
Cleared Dec 15, 2022
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with...
K222892 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 83d
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