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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
154057–154080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 03, 1984
FERTITUBE PREGNANCY TEST #1120
K832867 · JHJ
Stanbio Laboratory
Chemistry · 163d
Cleared Feb 03, 1984
QUALITATIVE ENZYME IMMUNOASSAY-DETECT
K832905 · LCX
Btc Diagnostics, Inc.
Chemistry · 158d
Cleared Feb 03, 1984
LABELED 125I ANTI-IGE
K833419 · DGC
Allergenetics
Immunology · 123d
Cleared Feb 03, 1984
RADOVAN SUBCUTANEOUS TISSUE EXPANDER
K833502 · LCJ
American Heyer Schulte
General & Plastic Surgery · 121d
Cleared Feb 03, 1984
VISIO-GEM
K833757 · EBF
Espe GmbH (Us)
Dental · 100d
Cleared Feb 03, 1984
WHITE BLOOD CELLS HUMAN TAND B
K833929 · LIZ
Control Diagnostics
Hematology · 108d