FDA DEVICE INTELLIGENCE

FDA Device Product Codes

FDA groups every regulated device under a three-letter product code — its classification regulation, device class, and review panel. Each code here carries its regulatory facts plus live market activity (510(k) clearances and PMA approvals) and recall history. All FDA data.

7,084 product codes · 2,401 Class I · 3,632 Class II · 531 Class III · 520 other

Most active product codes

Ranked by 510(k)/PMA clearance activity, with recall counts.

QIHClass II
Automated Radiological Image Processing Software
164 clearances · Radiology
GEXClass II
Powered Laser Surgical Instrument
140 clearances · General, Plastic Surgery
HRSClass II
Plate, Fixation, Bone
113 clearances · Orthopedic
LLZClass II
System, Image Processing, Radiological
105 clearances · Radiology
GEIClass II
Electrosurgical, Cutting & Coagulation & Accessories
103 clearances · General, Plastic Surgery
IYNClass II
System, Imaging, Pulsed Doppler, Ultrasonic
101 clearances · Radiology
OLOClass II
Orthopedic Stereotaxic Instrument
79 clearances · Neurology
ITIClass II
Wheelchair, Powered
73 clearances · Physical Medicine
NHAClass II
Abutment, Implant, Dental, Endosseous
71 clearances · Dental
OHSClass II
Light Based Over The Counter Wrinkle Reduction
67 clearances · General, Plastic Surgery
MAXClass II
Intervertebral Fusion Device With Bone Graft, Lumbar
59 clearances · Orthopedic
DZEClass II
Implant, Endosseous, Root-Form
58 clearances · Dental
HGXClass II
Pump, Breast, Powered
58 clearances · Obstetrics/Gynecology
NKBClass II
Thoracolumbosacral Pedicle Screw System
55 clearances · Orthopedic
DXNClass II
System, Measurement, Blood-Pressure, Non-Invasive
53 clearances · Cardiovascular
MBIClass II
Fastener, Fixation, Nondegradable, Soft Tissue
52 clearances · Orthopedic
GCJClass II
Laparoscope, General & Plastic Surgery
48 clearances · Gastroenterology, Urology
JAKClass II
System, X-Ray, Tomography, Computed
46 clearances · Radiology
LNHClass II
System, Nuclear Magnetic Resonance Imaging
45 clearances · Radiology
DQKClass II
Computer, Diagnostic, Programmable
44 clearances · Cardiovascular
EBFClass II
Material, Tooth Shade, Resin
41 clearances · Dental
OHTClass II
Light Based Over-The-Counter Hair Removal
40 clearances · General, Plastic Surgery
QJPClass II
Catheter, Percutaneous, Neurovasculature
39 clearances · Cardiovascular
DYBClass II
Introducer, Catheter
37 clearances · Cardiovascular
LZAClass I
Polymer Patient Examination Glove
35 clearances · General Hospital
OWBClass II
Interventional Fluoroscopic X-Ray System
35 clearances · Radiology
HSBClass II
Rod, Fixation, Intramedullary And Accessories
34 clearances · Orthopedic
FROUnclassified
Dressing, Wound, Drug
33 clearances · Unknown
DQYClass II
Catheter, Percutaneous
32 clearances · Cardiovascular
INIClass II
Vehicle, Motorized 3-Wheeled
32 clearances · Physical Medicine
LOMClass II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
32 clearances · Microbiology
EIHClass II
Powder, Porcelain
31 clearances · Dental
HWCClass II
Screw, Fixation, Bone
31 clearances · Orthopedic
MQVClass II
Filler, Bone Void, Calcium Compound
30 clearances · Orthopedic
ODPClass II
Intervertebral Fusion Device With Bone Graft, Cervical
30 clearances · Orthopedic
JWHClass II
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
29 clearances · Orthopedic
QASClass II
Radiological Computer-Assisted Triage And Notification Software
29 clearances · Radiology
EOQClass II
Bronchoscope (Flexible Or Rigid)
28 clearances · Ear, Nose, Throat
DQAClass II
Oximeter
27 clearances · Cardiovascular
PHXClass II
Shoulder Prosthesis, Reverse Configuration
27 clearances · Orthopedic
NRYClass II
Catheter, Thrombus Retriever
26 clearances · Cardiovascular
IRPClass II
Massager, Powered Inflatable Tube
25 clearances · Physical Medicine
KGNUnclassified
Wound Dressing With Animal-Derived Material(S)
25 clearances · Unknown
DQXClass II
Wire, Guide, Catheter
24 clearances · Cardiovascular
NAYClass II
System, Surgical, Computer Controlled Instrument
24 clearances · Gastroenterology, Urology
FMFClass II
Syringe, Piston
23 clearances · General Hospital
LPLClass II
Lenses, Soft Contact, Daily Wear
23 clearances · Ophthalmic
LZOClass II
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
23 clearances · Orthopedic
MUJClass II
System, Planning, Radiation Therapy Treatment
23 clearances · Radiology
NUCClass II
Lubricant, Personal
23 clearances · Obstetrics/Gynecology
NUHClass II
Stimulator, Nerve, Transcutaneous, Over-The-Counter
23 clearances · Neurology
GEHClass II
Unit, Cryosurgical, Accessories
22 clearances · General, Plastic Surgery
IYEClass II
Accelerator, Linear, Medical
22 clearances · Radiology
QEWClass II
Peripheral Mechanical Thrombectomy With Aspiration
22 clearances · Cardiovascular
FGBClass II
Ureteroscope And Accessories, Flexible/Rigid
21 clearances · Gastroenterology, Urology
IZLClass II
System, X-Ray, Mobile
21 clearances · Radiology
JWYClass II
Manual Antimicrobial Susceptibility Test Systems
21 clearances · Microbiology
LPHClass II
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
21 clearances · Orthopedic
NFOClass II
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
21 clearances · Neurology
OVDClass II
Intervertebral Fusion Device With Integrated Fixation, Lumbar
21 clearances · Orthopedic
LRKClass II
Device, Anti-Snoring
20 clearances · Dental
NGXClass II
Stimulator, Muscle, Powered, For Muscle Conditioning
20 clearances · Physical Medicine
NXCClass II
Aligner, Sequential
20 clearances · Dental
OURClass II
Sacroiliac Joint Fixation
20 clearances · Orthopedic
BZDClass II
Ventilator, Non-Continuous (Respirator)
19 clearances · Anesthesiology
EBIClass II
Resin, Denture, Relining, Repairing, Rebasing
19 clearances · Dental
FMIClass II
Needle, Hypodermic, Single Lumen
19 clearances · General Hospital
IORClass I
Wheelchair, Mechanical
19 clearances · Physical Medicine
KPSClass II
System, Tomography, Computed, Emission
19 clearances · Radiology
KWQClass II
Appliance, Fixation, Spinal Intervertebral Body
19 clearances · Orthopedic
MYNClass II
Analyzer, Medical Image
19 clearances · Radiology
QOFClass II
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
19 clearances · Microbiology
CAWClass II
Generator, Oxygen, Portable
18 clearances · Anesthesiology
FOZClass II
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
18 clearances · General Hospital
FRGClass II
Wrap, Sterilization
18 clearances · General Hospital
GXYClass II
Electrode, Cutaneous
18 clearances · Neurology
MBHClass II
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
18 clearances · Orthopedic
OAPClass II
Laser, Comb, Hair
18 clearances · Physical Medicine
OVEClass II
Intervertebral Fusion Device With Integrated Fixation, Cervical
18 clearances · Orthopedic
SBFClass II
Orthopedic Augmented Reality
18 clearances · Neurology
EZDClass II
Catheter, Straight
17 clearances · Gastroenterology, Urology
FAJClass II
Cystoscope And Accessories, Flexible/Rigid
17 clearances · Gastroenterology, Urology
KCTClass II
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
17 clearances · General Hospital
KNWClass II
Instrument, Biopsy
17 clearances · Gastroenterology, Urology
KTTClass II
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
17 clearances · Orthopedic
OBPClass II
Transcranial Magnetic Stimulator
17 clearances · Neurology
QKBClass II
Radiological Image Processing Software For Radiation Therapy
17 clearances · Radiology
FEDClass II
Endoscopic Access Overtube, Gastroenterology-Urology
16 clearances · Gastroenterology, Urology
FPAClass II
Set, Administration, Intravascular
16 clearances · General Hospital
KRDClass II
Device, Vascular, For Promoting Embolization
16 clearances · Cardiovascular
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