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

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176,076 results
52441–52464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2009
S8 ASPEN WITH H4I PLUS
K091947 · BZD
Resmed, Ltd.
Anesthesiology · 90d
Cleared Sep 28, 2009
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
K091981 · HQF
Lightmed Corp.
Ophthalmic · 89d
Cleared Sep 28, 2009
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · OLO
Mako Surgical Corp.
Orthopedic · 88d
Cleared Sep 28, 2009
IROOT BP PLUS
K092715 · KIF
Innovative Bioceramix, Inc.
Dental · 25d
Cleared Sep 28, 2009
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
K092756 · ITX
Ge Vingmed Ultrasound AS
Radiology · 19d
Cleared Sep 25, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082648 · LYZ
Tangshan Dar Plastic & Rubber...
General Hospital · 379d
Cleared Sep 25, 2009
SONOWAND INVITE
K083597 · HAW
Sonowand AS
Neurology · 294d
Cleared Sep 25, 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25,...
K083868 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 270d
Cleared Sep 25, 2009
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183 · KNQ
Cook Endoscopy
Gastroenterology & Urology · 242d
Cleared Sep 25, 2009
CONDUCTOR CORONARY GUIDEWIRE
K090193 · DQX
Concert Medical, LLC
Cardiovascular · 241d
Cleared Sep 25, 2009
ALPHA DUO LAP INSUFFLATOR
K090652 · HIF
Hippokratec GmbH
Obstetrics & Gynecology · 198d
Cleared Sep 25, 2009
BIOMET MODULAR FEMORAL REVISION SYSTEM
K090757 · KWA
Biomet, Inc.
Orthopedic · 186d
Cleared Sep 25, 2009
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
K091213 · FOS
Footprint Medical
General Hospital · 151d
Cleared Sep 25, 2009
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
K091214 · FOS
Footprint Medical
General Hospital · 151d
Cleared Sep 25, 2009
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
K091280 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 147d
Cleared Sep 25, 2009
KNEEALIGN SYSTEM
K091411 · OLO
Orthalign, Inc.
Orthopedic · 135d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · JJX
Roche Diagnostics Corp.
Chemistry · 114d
Cleared Sep 25, 2009
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
K091735 · EMA
S & C Polymer GmbH
Dental · 106d
Cleared Sep 25, 2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
K091825 · DQX
Abbott Vascular, Inc.
Cardiovascular · 98d
Cleared Sep 25, 2009
ELEGANT
K091826 · EIH
3M Espe AG Dental Products
Dental · 98d
Cleared Sep 25, 2009
NOBELPROCERA ZI ABUTMENT
K091904 · NHA
Nobel Biocare AB
Dental · 92d
Cleared Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX,...
K091946 · MQP
Stryker Spine
Orthopedic · 87d
Cleared Sep 25, 2009
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE)...
K092012 · FXX
Primed Medical Products, Inc.
General Hospital · 81d
Cleared Sep 25, 2009
SPINAL USA INTERBODY CAGES
K092193 · MAX
Spinal USA
Orthopedic · 66d