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
75625–75648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2002
SECURE SOFT
K021437 · EBI
Imtec Corp.
Dental · 74d
Cleared Jul 19, 2002
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
K021475 · FMI
Bd
General Hospital · 72d
Cleared Jul 19, 2002
LIGHT CURE DENTAL DAM
K021524 · EIE
Prime Dental Manufacturing, Inc.
Dental · 70d
Cleared Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · DCN
Beckman Coulter, Inc.
Immunology · 66d
Cleared Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · LBS
Jas Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 19, 2002
ADMIRA PROTECT
K021844 · EBC
Voco GmbH
Dental · 44d
Cleared Jul 19, 2002
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS...
K022000 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 19, 2002
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
K022026 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 19, 2002
STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM...
K022033 · JEY
Bioplate, Inc.
Dental · 28d
Cleared Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049 · CJY
Hemagen Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 18, 2002
REPROCESSED FEMORAL COMPRESSION DEVICE
K012574 · NMF
Sterilmed, Inc.
Cardiovascular · 343d
Cleared Jul 18, 2002
QIZHOU ACUPUNCTURE NEEDLE
K013926 · MQX
Wujiang City Shenli Medical and...
General Hospital · 232d
Cleared Jul 18, 2002
STEAMPLUS STERILIZATION TEST
K020409 · JOJ
Spsmedical Supply Corp.
General Hospital · 161d
Cleared Jul 18, 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275 · MNI
Micomed Ortho GmbH
Orthopedic · 87d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · CDZ
bioMerieux, Inc.
Chemistry · 83d
Cleared Jul 18, 2002
V-2100G ADVANCED INFANT INCUBATOR
K021809 · FMZ
Atom Medical Corp
General Hospital · 45d
Cleared Jul 18, 2002
GALT MEDICAL GUIDEWIRE
K021990 · DQX
Galt Medical Corp.
Cardiovascular · 30d
Cleared Jul 18, 2002
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
K021991 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 18, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 18, 2002
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
K022165 · FTC
Theralight, Inc.
General & Plastic Surgery · 15d
Cleared Jul 17, 2002
HLS NOETOS SYSTEM
K013906 · JWH
Tornier
Orthopedic · 233d
Cleared Jul 17, 2002
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020413 · LON
Dade Behring, Inc.
Microbiology · 160d
Cleared Jul 17, 2002
BAYER RAPIDPOINT 405 SYSTEM
K020616 · GKR
Bayer Diagnostics Corp.
Hematology · 142d
Cleared Jul 17, 2002
SURGERY AND ACCESSORIES
K021236 · LLZ
Camtronics, Ltd.
Radiology · 90d