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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
51601–51624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2009
DISCOVERY MODEL NM/CT 670
K093514 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 27d
Cleared Dec 10, 2009
ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY...
K093525 · CCK
Ventlab Corp.
Anesthesiology · 24d
Cleared Dec 10, 2009
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K093714 · ITX
Medison Co., Ltd.
Radiology · 8d
Cleared Dec 09, 2009
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO,...
K091884 · NWM
ARK Diagnostics, Inc.
Toxicology · 168d
Cleared Dec 09, 2009
EIDOSMED, MODEL EDG4.0
K091992 · OOL
Eidosmed, LLC
Orthopedic · 160d
Cleared Dec 09, 2009
WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
K092914 · MBI
Medshape Solutions
Orthopedic · 78d
Cleared Dec 09, 2009
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL...
K093332 · FRN
Delphi Medical Systems
General Hospital · 44d
Cleared Dec 09, 2009
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER...
K093750 · KRA
Ev3, Inc.
Cardiovascular · 2d
Cleared Dec 08, 2009
SD CHECK GOLD
K082683 · NBW
Standard Diagnostics, Inc.
Chemistry · 449d
Cleared Dec 08, 2009
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
K083371 · GWF
Natus Medical, Inc.
Neurology · 389d
Cleared Dec 08, 2009
ARROWBONE-A, ARROWBONE-B
K083372 · LYC
Brainbase Corporation
Dental · 389d
Cleared Dec 08, 2009
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
K090686 · JDQ
Sic Brevetti S.R.L.
Orthopedic · 267d
Cleared Dec 08, 2009
BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM
K091051 · DZE
Tita-Link
Dental · 239d
Cleared Dec 08, 2009
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
K091457 · GWF
Nexstim OY
Neurology · 204d
Cleared Dec 08, 2009
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150,...
K092032 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 155d
Cleared Dec 08, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092966 · LYZ
Jin Zhou Chang Hao Plastic Products...
General Hospital · 74d
Cleared Dec 08, 2009
CROSSCATH SUPPORT CATHTER
K093052 · KRA
Cook, Inc.
Cardiovascular · 69d
Cleared Dec 08, 2009
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS,...
K093312 · KGC
Kimberly-Clark Corp.
Gastroenterology & Urology · 47d
Cleared Dec 07, 2009
DS-A BLOOD GLUCOSE MONITORING SYSTEM
K082965 · CGA
Alliance International Co., Ltd.
Chemistry · 430d
Cleared Dec 07, 2009
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS...
K091198 · KKO
Allied Hill Enterprises, Ltd.
Dental · 227d
Cleared Dec 07, 2009
WATERLASE MD, MODEL 7100102
K091746 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 174d
Cleared Dec 07, 2009
E-PULSE
K091875 · BWK
Medevice Corporation
Neurology · 167d
Cleared Dec 07, 2009
ALATUS VAGINAL BALLOON PACKING SYSTEM
K092534 · JAQ
Radiadyne
Radiology · 110d
Cleared Dec 07, 2009
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK,...
K092782 · LHI
Carmel Pharma Ab.
General Hospital · 88d