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
78385–78408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2001
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K013176 · EHD
Afp Imaging Corp.
Radiology · 22d
Cleared Oct 16, 2001
MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
K013215 · BXM
Nuvasive, Inc.
Anesthesiology · 20d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235 · JJY
Beckman Coulter, Inc.
Chemistry · 18d
Cleared Oct 16, 2001
HAC-420 HEAD ARRAY COIL
K013322 · MOS
Mri Devices Corp.
Radiology · 11d
Cleared Oct 15, 2001
TORAYSULFONE DIALYZER
K002512 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 426d
Cleared Oct 15, 2001
PAM-RL
K010997 · GWQ
Individual Monitoring Systems, Inc.
Neurology · 195d
Cleared Oct 15, 2001
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K011283 · NGT
The Kendall Company
General Hospital · 171d
Cleared Oct 15, 2001
MERTEX-PLUS REUSABLE SURGICAL DRAPE
K012237 · KKX
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
K012240 · FYA
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
CHIBA NEEDLE
K012358 · FCG
Ispg, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 15, 2001
EAR MUFFINS
K012384 · HCC
Bio-Logic Systems Corp.
Neurology · 80d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · DJR
ACON Laboratories, Inc.
Toxicology · 66d
Cleared Oct 15, 2001
FAS ENDOLUMINAL BRUSH
K012641 · LJS
Fas Medical , Ltd.
General Hospital · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
POWDERED LATEX EXAMINATION GLOVES
K013026 · LYY
Great Glove (Thailand) Co. , Ltd.
General Hospital · 35d
Cleared Oct 15, 2001
MODIFICATION TO ALPHA DX SYSTEM
K013118 · JHX
First Medical, Inc.
Chemistry · 27d
Cleared Oct 15, 2001
MT ALERT INFUSION MONITOR
K013121 · FLN
Sierra Biosearch, Inc.
General Hospital · 27d
Cleared Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600...
K013134 · DHB
Diagnostic Products Corp.
Immunology · 26d
Cleared Oct 15, 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · FPA
Terumo Medical Corp.
General Hospital · 24d
Cleared Oct 12, 2001
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR...
K004005 · QPB
Mentor Corp.
General & Plastic Surgery · 290d
Cleared Oct 12, 2001
MAGELLAN-2200, MODEL 1
K010613 · BSZ
Oceanic Medical Products, Inc.
Anesthesiology · 225d
Cleared Oct 12, 2001
CYCLOTEC AMT CTI TENS DEVICE
K010615 · GZJ
Cyclotec
Neurology · 225d
Cleared Oct 12, 2001
INSTRUMENT DAMPING PORT
K011373 · DRC
Medcanica, Inc.
Cardiovascular · 161d