FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89617–89640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1998
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812 · HRS
Arthrex, Inc.
Orthopedic · 246d
Cleared Jun 10, 1998
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
K980047 · KQO
Yeongdong Pharmaceutical Corp.
Chemistry · 155d
Cleared Jun 10, 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121 · KWP
Aesculap, Inc.
Orthopedic · 147d
Cleared Jun 10, 1998
STERILE, POWDERFREE LATEX EXAMINATION GLOVE
K980785 · LYY
London Intl., LLC
General Hospital · 100d
Cleared Jun 10, 1998
KAPLAN-SIMPSON INFUSASLEEVE II
K980957 · QEY
Localmed, Inc.
Cardiovascular · 86d
Cleared Jun 10, 1998
IN-CHECK INSPIRATORY FLOWMETER
K980960 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 86d
Cleared Jun 10, 1998
ROGACHEFSKY DISTAL RADIUS PLATES
K981283 · HRS
Howmedica, Inc.
Orthopedic · 63d
Cleared Jun 10, 1998
ACE T UPTAKE REAGENT TU CALIBRATORS
K981375 · KHQ
Schiapparelli Biosystems, Inc.
Chemistry · 55d
Cleared Jun 10, 1998
ACE T4 REAGENT T4 CALIBRATORS
K981377 · KLI
Schiapparelli Biosystems, Inc.
Chemistry · 55d
Cleared Jun 10, 1998
EVANESCE SCAR MANAGEMENT SYSTEM
K981387 · MDA
Medical Scientific, Inc.
General & Plastic Surgery · 55d
Cleared Jun 10, 1998
TC SERIES (TRANSPORT)
K981418 · IOR
Get A Life-Give A Living Plus Kids...
Physical Medicine · 51d
Cleared Jun 10, 1998
TC SERIES (TILT RECLINER)
K981419 · IOR
Get A Life-Give A Living Plus Kids...
Physical Medicine · 51d
Cleared Jun 10, 1998
TC SERIES (WIDE)
K981420 · IOR
Get A Life-Give A Living Plus Kids...
Physical Medicine · 51d
Cleared Jun 10, 1998
TC SERIES (RECLINER)
K981421 · IOR
Get A Life-Give A Living Plus Kids...
Physical Medicine · 51d
Cleared Jun 10, 1998
TC SERIES
K981422 · IOR
Get A Life-Give A Living Plus Kids...
Physical Medicine · 51d
Cleared Jun 10, 1998
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE
K981477 · KNW
Medical Biopsy, Inc.
Gastroenterology & Urology · 47d
Cleared Jun 10, 1998
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495 · JHS
Diagnostic Products Corp.
Chemistry · 44d
Cleared Jun 10, 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY...
K981590 · DIF
Bio-Rad
Toxicology · 37d
Cleared Jun 09, 1998
DEEGLITE
K974583 · OLV
Grass-Telefactor Product Group
Neurology · 203d
Cleared Jun 09, 1998
WINSCAN AUTOMATED IMAGING SYSTEM
K980375 · JOY
Applied Imaging Corp.
Hematology · 130d
Cleared Jun 09, 1998
SUPERGLOVES
K980494 · LYY
Supermax Sdn Bhd
General Hospital · 120d
Cleared Jun 09, 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653 · FGE
Cordis Corp.
Gastroenterology & Urology · 118d
Cleared Jun 09, 1998
RUSCH SILICONE FOLEY CATHETER
K980870 · EZL
Rusch, Inc.
Gastroenterology & Urology · 97d
Cleared Jun 09, 1998
LONE STAR IMPRESSION SYSTEMS
K980968 · ELW
Lone Star Technologies
Dental · 85d