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
79177–79200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · LHI
Bioject, Inc.
General Hospital · 34d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9068 T
K010653 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9078 T
K010654 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 30d
Cleared Apr 05, 2001
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K010829 · LYZ
General Gloves Corp.
General Hospital · 16d
Cleared Apr 05, 2001
THE LIBERATOR WHEELCHAIR
K010859 · ITI
Liberator Wheelchairs, Inc.
Physical Medicine · 14d
Cleared Apr 05, 2001
STS-T LITHOTRIPTER, MODEL STS-T
K010900 · LNS
Medstone Intl., Inc.
Gastroenterology & Urology · 10d
Cleared Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · DRB
Medtronic Vascular
Cardiovascular · 10d
Cleared Apr 05, 2001
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K010912 · MSX
Data Critical Corp.
Cardiovascular · 9d
Cleared Apr 04, 2001
FLO-BOOT
K003272 · BXB
Discovery Group, LLC
Physical Medicine · 168d
Cleared Apr 04, 2001
MINI FIBER ENDOSCOPES
K003417 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 153d
Cleared Apr 04, 2001
IVS TUNNELLER
K010035 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Apr 04, 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · DXC
Cardiothoracic Systems, Inc.
Cardiovascular · 78d
Cleared Apr 04, 2001
SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL...
K010737 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 23d
Cleared Apr 04, 2001
STANNAH POWER CHAIR, MODEL 201
K994083 · IPL
Stannah Power Chairs , Ltd.
Physical Medicine · 488d
Cleared Apr 03, 2001
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · FXX
White Knight Healthcare, Inc.
General Hospital · 286d
Cleared Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · MOS
GE Medical Systems
Radiology · 132d
Cleared Apr 03, 2001
ULTRASOUND SCANNER TYPE 2102
K003986 · IYN
B & K Medical A/S
Radiology · 98d
Cleared Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074 · MOS
Medical Advances, Inc.
Radiology · 84d
Cleared Apr 03, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · LZA
Shen Wei (Usa), Inc.
General Hospital · 81d
Cleared Apr 03, 2001
THINKINGNET
K010271 · LLZ
Thinking Systems Corp.
Radiology · 64d
Cleared Apr 03, 2001
ADVIA RETIC PLUS
K010461 · JPK
R&D Systems, Inc.
Hematology · 46d
Cleared Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
K010558 · MLE
Inova Diagnostics, Inc.
Immunology · 36d