Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
80305–80328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 03, 2001
MAMMOGRAPH
K010792 · IZH
Digitec Medical Service Corp.
Radiology · 18d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
K010860 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 02, 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · FXX
White Knight Healthcare, Inc.
General Hospital · 285d
Cleared Apr 02, 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · FXX
White Knight Healthcare, Inc.
General Hospital · 276d
Cleared Apr 02, 2001
AT3C70 TRANSDUCER
K002856 · ITX
Sonora Medical Systems
Radiology · 201d
Cleared Apr 02, 2001
CYNOSURE PHOTOGENICA DL
K010005 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d