FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125713–125736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1990
ISOFLO(TM) AMNIOCENTESIS TRAY
K901643 · HIO
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 107d
Cleared Jul 25, 1990
KODAK M35A-M X-OMAT PROCESSOR
K901772 · IXW
Eastman Kodak Company
Radiology · 97d
Cleared Jul 25, 1990
COMFORTRAC TABLE MODEL CT-1000
K901971 · JFB
Comfortrac Systems
Physical Medicine · 85d
Cleared Jul 25, 1990
DIGITAL MANOMETER (DM 50)
K901998 · BXR
Medical Support Products, Inc.
Anesthesiology · 84d
Cleared Jul 25, 1990
SOEHENDRA LITHOTRIPSY SET
K902170 · LQC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 25, 1990
KRONAMAX HUMAN PERFORMANCE LAB
K902219 · IKK
Physicians Digital Co.
Physical Medicine · 70d
Cleared Jul 25, 1990
HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
K902664 · IQA
Prentke Romich Co.
Physical Medicine · 37d
Cleared Jul 25, 1990
MODEL 9000 AT ANKLE CPM DEVICE
K902707 · BXB
Sutter Corp.
Physical Medicine · 36d
Cleared Jul 25, 1990
ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS
K902713 · CAC
Diemolding Corp.
Anesthesiology · 35d
Cleared Jul 25, 1990
MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY)
K902795 · INO
The Healthcare Group, Inc.
Physical Medicine · 29d
Cleared Jul 25, 1990
LIBERTY HOT PACK AND LIBERTY KOLD PACK
K902839 · IMD
Liberty Ent.
Physical Medicine · 27d
Cleared Jul 25, 1990
INFRASSAGE MASSAGER
K902895 · IRT
Conair Corp.
Physical Medicine · 22d
Cleared Jul 25, 1990
SHOWER-A-WAY
K902951 · INN
Tri-S-Sales and Mfg.
Physical Medicine · 20d
Cleared Jul 25, 1990
MINI-VIBRATOR
K903098 · IRO
Frank J. Biehl
Physical Medicine · 12d
Cleared Jul 24, 1990
TENSTAPLE ORTHOPEDIC STAPLING SYSTEM
K896471 · JDR
Tenstaple, Inc.
Orthopedic · 253d
Cleared Jul 24, 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · FOZ
Arrow Intl., Inc.
General Hospital · 187d
Cleared Jul 24, 1990
R-BAND(TM) RESPIRATORY SENSOR
K900264 · BZQ
Buckman Co., Inc.
Anesthesiology · 187d
Cleared Jul 24, 1990
BIODEX LIFT SIMULATOR
K900450 · IKK
Biodex Corp.
Physical Medicine · 175d
Cleared Jul 24, 1990
BEHRING CHROMOTIMER
K901829 · JJQ
Behring Diagnostics, Inc.
Hematology · 91d
Cleared Jul 24, 1990
L.D.X LIPID MONITORING SYSTEM
K901900 · CHH
Cholestech Corp.
Chemistry · 88d
Cleared Jul 24, 1990
AUTOWAND(TM) 7XXX SERIES
K902059 · CAC
Boehringer Laboratories
Anesthesiology · 78d
Cleared Jul 24, 1990
FESAN SUNGLASSES
K902117 · HQY
Fesan, S.A.
Ophthalmic · 76d
Cleared Jul 24, 1990
SUNGLASSES
K902186 · HQY
Creative Paper Products, Inc.
Ophthalmic · 71d
Cleared Jul 24, 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
K902455 · LCP
Analytical Control Systems, Inc.
Hematology · 50d