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
159625–159648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1982
DIGITAL PULSE METER (73 BWS) #HRM-100E
K822692 · DRT
Sanyo Electric, Inc.
Cardiovascular · 38d
Cleared Oct 15, 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · DRT
Hewlett-Packard Co.
Cardiovascular · 38d
Cleared Oct 15, 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · DYG
American Edwards Laboratories
Cardiovascular · 38d
Cleared Oct 15, 1982
ROOMATE II
K822789 · CAW
Cryogenic Assoc.
Anesthesiology · 30d
Cleared Oct 15, 1982
DISPOSABLE ELECTRODE #1900
K822798 · DRX
Andover Medical, Inc.
Cardiovascular · 29d
Cleared Oct 15, 1982
MICROFLEX-VENOFLUX
K822836 · FPA
Exco, Inc.
General Hospital · 24d
Cleared Oct 15, 1982
PRIMARY & SECONDARY I.V. TUBING SETS
K822848 · FPA
David Simmonds Co., Inc.
General Hospital · 22d
Cleared Oct 15, 1982
PRO MED 100
K822854 · GZJ
Rebco Trading Co.
Neurology · 18d
Cleared Oct 15, 1982
MODEL 325D UNIPOLAR CARDIAC PULSE GEN
K822904 · DXY
Cook Pacemaker Corp.
Cardiovascular · 16d
Cleared Oct 15, 1982
PHYSICAL MEDICINE & REHABILITATION EQUIP
K822906 · ION
I-Rep, Inc.
Physical Medicine · 16d
Cleared Oct 14, 1982
SYMPTOTHERM 8 FERTILITY INDICATOR
K821507 · LHD
Ovix Corp., Inc.
Obstetrics & Gynecology · 147d
Cleared Oct 13, 1982
DUODERM HYDROACTIVE GRANULES
K821655 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 131d
Cleared Oct 13, 1982
FRANCIS NASAL TUBE
K822130 · FZE
Tekna Med Corp.
General & Plastic Surgery · 86d
Cleared Oct 13, 1982
OPEN HEART TRAY (CUSTOM DESIGNED)
K822158 · KDD
Megaplast, Inc.
General & Plastic Surgery · 82d
Cleared Oct 13, 1982
NAGASHIMA SN OPERATOR'S CHAIR
K822264 · GBB
Kelleher Corp.
General & Plastic Surgery · 76d
Cleared Oct 13, 1982
TRANSFORMER
K822267
Kelleher Corp.
Gastroenterology & Urology · 76d
Cleared Oct 13, 1982
BX-500 ELECTRONIC MUSCLE EXERCISER
K822287 · IPF
Bloomex International, Inc.
Physical Medicine · 75d
Cleared Oct 13, 1982
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · FIP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 65d
Cleared Oct 13, 1982
INNOCOMB LICE COMB
K822421 · LJL
Innovative Products, Inc.
General Hospital · 58d
Cleared Oct 13, 1982
BABY TEMP PACIFIER
K822423 · FQZ
Trp Energy Sensors, Inc.
General Hospital · 62d
Cleared Oct 13, 1982
ACUFEX MAGNETIC RETRIEVER
K822439
Acufex Microsurgical, Inc.
General & Plastic Surgery · 61d
Cleared Oct 13, 1982
SUCTION CATHETER W/STERILE WATER
K822510 · GBX
Medine Dynacor
General & Plastic Surgery · 54d
Cleared Oct 13, 1982
HAWKINS EBA -16 MUSCLE STIMULATOR
K822519 · IPF
A-Zenith Therapeutic Equipment/Supply
Physical Medicine · 51d
Cleared Oct 13, 1982
SPECIAL EYE MIRROR
K822529
Wilmington Optics, Inc.
Ophthalmic · 51d