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
82633–82656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2000
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891 · GKP
Bio/Data Corp.
Hematology · 21d
Cleared Jul 12, 2000
AMPLATZER SIZING BALLOON
K993248 · MJN
Aga Medical Corp.
Cardiovascular · 288d
Cleared Jul 11, 2000
PUMA DENTAL CHAIR AND UNIT
K000837 · EIA
Castellini S.P.A.
Dental · 120d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · FYA
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 11, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K001194 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 11, 2000
INSIDE VIEW
K001217 · GCM
Monadnock Optics, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231 · HWC
New Deal, S.A.
Orthopedic · 85d
Cleared Jul 11, 2000
BIOINSULATED SILICONE PUNCTUM PLUG
K001234 · LZU
Advanced Vision Science
Ophthalmic · 85d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jul 11, 2000
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256...
K001324 · OLT
Neuro Scan Labs
Neurology · 76d
Cleared Jul 11, 2000
SCULPTURE FLOW
K001623 · EBF
Jeneric/Pentron, Inc.
Dental · 46d
Cleared Jul 11, 2000
NEEDLELESS TRANSFER DEVICE
K001831 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 25d
Cleared Jul 11, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
K001837 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 25d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001861 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001863 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC...
K990144 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 539d
Cleared Jul 10, 2000
SENSATION -VACUUM ASSIST DEVICES
K000124 · LKY
Prosurg, Inc.
Gastroenterology & Urology · 174d
Cleared Jul 10, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K001214 · LPN
Alcon Universal, Ltd.
Ophthalmic · 87d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · DJC
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · GAW
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812 · KGI
Lunar Corp.
Radiology · 25d
Cleared Jul 10, 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Jul 10, 2000
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
K994409 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 195d
Cleared Jul 07, 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · DTK
Cordis Corp.
Cardiovascular · 179d