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
79369–79392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2001
GASTRIC SUCTION AND DRAINAGE CATHETER
K002838 · KNT
Bioenterics Corp.
Gastroenterology & Urology · 300d
Cleared Jul 09, 2001
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
K003254 · FPA
Mission Medicl Devices
General Hospital · 265d
Cleared Jul 09, 2001
SPINE WORKS COLLAR
K003662 · HAX
Spine Works
Neurology · 223d
Cleared Jul 09, 2001
US SENSOR #CG-930P
K003876 · HEL
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 206d
Cleared Jul 09, 2001
BRAIDED GUIDING INTRODUCER
K004026 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 194d
Cleared Jul 09, 2001
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
K010235 · FLL
Oriental System Technology, Inc.
General Hospital · 165d
Cleared Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · DIO
ACON Laboratories, Inc.
Toxicology · 110d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871 · CDT
Dade Behring, Inc.
Chemistry · 108d
Cleared Jul 09, 2001
GUIDEWIRE INTRODUCER SAFETY NEEDLE
K011085 · DYB
Medamicus, Inc.
Cardiovascular · 90d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jul 09, 2001
MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN...
K011117 · MEB
Mps Acacia
General Hospital · 88d
Cleared Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K011342 · GKZ
Beckman Coulter, Inc.
Hematology · 68d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · CJY
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 09, 2001
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE...
K011482 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 56d
Cleared Jul 09, 2001
EASY CONTROL MICRO INSERTER, MODEL ON385
K011498 · NCE
Ophtec USA, Inc.
Ophthalmic · 55d
Cleared Jul 09, 2001
MMODIFICATION TO LAMINARIA
K011512 · HDY
A & A Medical, Inc.
Obstetrics & Gynecology · 54d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
K011566 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · MSQ
Oridion Medical 1987 , Ltd.
Microbiology · 53d
Cleared Jul 09, 2001
BW ACUPUNCTURE NEEDLES
K011669 · MQX
H F Intl. Co.
General Hospital · 40d
Cleared Jul 09, 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE,...
K011728 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 35d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · DTN
Medtronic Vascular
Cardiovascular · 25d
Cleared Jul 09, 2001
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND...
K011895 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 21d