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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74497–74520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · JHX
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jul 19, 2002
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 421d
Cleared Jul 19, 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · JLW
Awareness Technology, Inc.
Chemistry · 277d
Cleared Jul 19, 2002
KOLIBRI IGS SYSTEMS
K014256 · HAW
Brainlab AG
Neurology · 205d
Cleared Jul 19, 2002
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND...
K020910 · GXZ
The Electrode Store, Inc.
Neurology · 121d
Cleared Jul 19, 2002
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279 · MHX
Datex-Ohmeda
Cardiovascular · 88d
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