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
154897–154920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1984
BARD KARAYA GUM WASHERS
K834575 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
BIOSPAL 2400S
K834579 · KDT
Hospal Medical Corp.
Pathology · 37d
Cleared Feb 04, 1984
BIOSPAL (R) 1800S
K834589 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
STOPEX-CONDOMS-
K834591 · HIS
Tropex Worldwide, Inc.
Obstetrics & Gynecology · 37d
Cleared Feb 04, 1984
BLOOD TUBING
K834596 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 04, 1984
AUTOTECHNICON V TISSUE PROCESS SYS
K834599 · IEO
Technicon Instruments Corp.
Pathology · 36d
Cleared Feb 04, 1984
RESOLVE-HB
K840011 · GKA
Isolab, Inc.
Hematology · 31d
Cleared Feb 04, 1984
VERTEX PERCUTANEOUS CATHETER INTRODUC
K840017 · DRE
Professional Medical Services
Cardiovascular · 31d
Cleared Feb 04, 1984
HEART CATHETERIZATION TRAY SET
K840022 · DRE
Medi-Plast Intl., Inc.
Cardiovascular · 30d
Cleared Feb 04, 1984
OPERATING ROOM STAND
K840027 · FSE
Healthmate, Inc.
General & Plastic Surgery · 30d
Cleared Feb 04, 1984
LIFEPAK 7D
K840047 · DRO
Physio-Control Corp.
Cardiovascular · 29d
Cleared Feb 04, 1984
EXP* 500 PARALLEL PLATE DIALYZER
K840057 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 26d
Cleared Feb 04, 1984
SILITEK URINARY DIVERSION STENT
K840059 · FAD
Surgitek
Gastroenterology & Urology · 26d
Cleared Feb 04, 1984
ARTERIAL BLOOD GAS INTERPRETATION PROG
K840102 · CCE
M. D. Software, Inc.
Anesthesiology · 25d
Cleared Feb 04, 1984
ELECATH HEPARIN COATED TEMP. PACING
K840109 · LDF
Electro-Catheter Corp.
Cardiovascular · 25d
Cleared Feb 04, 1984
COAGULATION FACTOR DEFICIENT PLASMA
K840114 · GGP
Medical Specialties Laboratories
Hematology · 24d
Cleared Feb 04, 1984
EXP* 700 PARALLEL PLATE DIALYZER
K840146 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 22d
Cleared Feb 04, 1984
SUR-FIT UROSTOMY POUCH W/ACCUSEAL
K840166 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 19d
Cleared Feb 04, 1984
PORTABLE DEFIBRILLATOR
K840167 · LDD
Honeywell, Inc.
Cardiovascular · 19d
Cleared Feb 04, 1984
DRYDEN MINI BACTERIA FILTER
K840205 · CAH
Dryden Corp.
General Hospital · 16d
Cleared Feb 04, 1984
SERVO CART 170
K840264 · BZN
Siemens Elema AB
Anesthesiology · 12d
Cleared Feb 04, 1984
ROAD RUNNER ELECTRIC TREADMILL
K840280 · IOL
Battle Creek Equipment Co.
Physical Medicine · 12d
Cleared Feb 04, 1984
OVERHEAD WHIRLPOOL HAND SPA BRAND
K840282 · ILJ
Priest Enterprises, Inc.
Physical Medicine · 12d
Cleared Feb 04, 1984
CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV
K840313 · BWB
Imm Enterprises , Ltd.
Anesthesiology · 11d