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
81793–81816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2000
MDI GLIADIN A TEST
K002358 · MST
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
MDI GLIADIN G TEST
K002359 · MST
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
JETCAN HUBER NEEEDLE SET
K002471 · FPA
Pfm Produkte Fur Die Medizin AG
General Hospital · 69d
Cleared Oct 19, 2000
BIOMESH P1 AND BIOMESH PLUG AND PATCH
K002479 · FTL
Cousin Biotech S.A.R.L
General & Plastic Surgery · 69d
Cleared Oct 19, 2000
VITREA 2, VERSION 2.1
K002519 · LLZ
Vital Images, Inc.
Radiology · 65d
Cleared Oct 19, 2000
LUMALITE CURE LIGHT, MODEL 2100
K002566 · EBZ
Lumalite, Inc.
Dental · 63d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Oct 19, 2000
JEL BIOS PURE
K002645 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Oct 19, 2000
HARDYDISK NETILMICIN, 30MCG
K002663 · JTN
Hardy Diagnostics
Microbiology · 55d
Cleared Oct 19, 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · MSW
Beckman Coulter, Inc.
Immunology · 31d
Cleared Oct 19, 2000
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · KGO
Maxxim Medical
General Hospital · 29d
Cleared Oct 19, 2000
SPIRIT ACUPUNCTURE NEEDLE
K003010 · MQX
United Pacific Co., Ltd.
General Hospital · 23d
Cleared Oct 19, 2000
M2376A DEVICELINK SYSTEM
K003107 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · FPA
Baxter Healthcare Corp
General Hospital · 3d
Cleared Oct 18, 2000
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · DTK
Cook, Inc.
Cardiovascular · 216d
Cleared Oct 18, 2000
TRANSQ3
K001522 · KTB
Iomed, Inc.
Physical Medicine · 155d
Cleared Oct 18, 2000
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
K002204 · DTE
Pace Medical
Cardiovascular · 90d
Cleared Oct 18, 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · GWG
Image-Guided Neurologics, Inc.
Neurology · 78d
Cleared Oct 18, 2000
COLLAGEN WOUND DRESSING
K002443 · KGN
Oasis Research, LLC
General & Plastic Surgery · 70d
Cleared Oct 18, 2000
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
K002444 · IYE
Sun Nuclear Corp.
Radiology · 70d
Cleared Oct 18, 2000
SMARTLENS
K002510 · HKX
Odc Ophthalmic Development Co. AG
Ophthalmic · 64d
Cleared Oct 18, 2000
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
K002534 · DRB
Eupalamus, LLC
Cardiovascular · 63d
Cleared Oct 18, 2000
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2...
K002686 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 51d
Cleared Oct 18, 2000
KSEA UNIMAT 12
K002700 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d