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

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176,076 results
164209–164232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1981
ANESTHESIOLOGY DEVICE
K811430 · CAN
Vital Air Oxygen Co.
Anesthesiology · 18d
Cleared Jun 09, 1981
TECHNICON STAR SYSTEM
K811431 · JLW
Technicon Instruments Corp.
Chemistry · 18d
Cleared Jun 09, 1981
ACRATRAC R
K811438 · INW
Avratronics Corp.
Physical Medicine · 18d
Cleared Jun 09, 1981
RADIAL HEAD PROSTHESIS
K811451 · JDB
Cintor Orthopaedic Div.
Orthopedic · 18d
Cleared Jun 09, 1981
VANCE PROSTATIC ASPIRATION SET
K811454 · KNW
Vance Products, Inc.
Gastroenterology & Urology · 18d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE ASSAY
K811459 · LAO
Syva Co.
Chemistry · 14d
Cleared Jun 09, 1981
EMIT-CAD QUINIDINE ASSAY
K811460 · LBZ
Syva Co.
Toxicology · 14d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE CONTROL
K811461 · LAZ
Syva Co.
Toxicology · 14d
Cleared Jun 09, 1981
EMIT-CAD QUINDINE CONTROL
K811462 · LAS
Syva Co.
Toxicology · 14d
Cleared Jun 09, 1981
THERMODILUTION KIT
K811480 · KRB
American Pharmaseal Div. Ahsc
Cardiovascular · 13d
Cleared Jun 09, 1981
WAKO URIC ACID B TEST
K811504 · KNK
Wako Chemicals USA, Inc.
Chemistry · 13d
Cleared Jun 02, 1981
SUNLAMP
K803264 · FTC
Am Labs, Inc.
Radiology · 160d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · EXB
Howmedica Corp.
Gastroenterology & Urology · 77d
Cleared Jun 02, 1981
ADULT & PEDIATRIC TRACHEOSTOMY MASKS
K810946 · BYF
Airlife, Inc.
Anesthesiology · 56d
Cleared Jun 02, 1981
AIR ENTRAINMENT TRACH T
K810947 · BYF
Airlife, Inc.
Anesthesiology · 56d
Cleared Jun 02, 1981
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT
K810979 · KNT
Arrow Intl., Inc.
Gastroenterology & Urology · 53d
Cleared Jun 02, 1981
SOLUTION ADMINISTRATION SET
K811006 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 49d
Cleared Jun 02, 1981
RESPIRATORY SENSOR
K811014 · BZQ
Impact Instrumentation, Inc.
Anesthesiology · 48d
Cleared Jun 02, 1981
SUNLAMP
K811029 · FTC
Williams & Connolly
Radiology · 47d
Cleared Jun 02, 1981
KRYPTON MASKS & TUBING
K811118 · IYT
Medi-Physics Inc. Dba Nycomed...
Radiology · 39d
Cleared Jun 02, 1981
SUR-FIT IRRIGATION SLEEVE
K811160 · EXD
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 02, 1981
SURGICAL DRESSING SET
K811166
Washington-Greene County Branch...
General & Plastic Surgery · 35d
Cleared Jun 02, 1981
N-D0-SURE
K811185 · CBH
Ackrad Laboratories
Anesthesiology · 34d
Cleared Jun 02, 1981
VAC-RITE SUNCTION COLLECTION
K811192 · KDQ
Bd Becton Dickinson Vacutainer...
General Hospital · 33d