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
46633–46656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2011
SLIC SCREW REPAIR SYSTEM
K111608 · HWC
Acumed, LLC
Orthopedic · 81d
Cleared Aug 29, 2011
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
K112339 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Aug 29, 2011
SNAP WOUND CARE SYSTEM
K112341 · OKO
Spiracur, Inc.
General & Plastic Surgery · 14d
Cleared Aug 29, 2011
MATRISTEM WOUND MATRIX
K112409 · KGN
Acell, Inc.
General & Plastic Surgery · 7d
Cleared Aug 26, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI...
K102678 · NBW
Andon Medical Co., Ltd.
Chemistry · 344d
Cleared Aug 26, 2011
COVAMAX RESORBABLE COLLAGEN MEMBRANE
K103087 · NPL
Biom'Up Sas
Dental · 311d
Cleared Aug 26, 2011
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103181 · LLZ
Genoray Co., Ltd.
Radiology · 302d
Cleared Aug 26, 2011
AUTOREADER 2
K103532 · LRG
Trek Diagnostic Systems
Microbiology · 268d
Cleared Aug 26, 2011
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
K110269 · BTR
Well Lead Medical Co., Ltd.
Anesthesiology · 211d
Cleared Aug 26, 2011
ENDOWRIST ONE SUCTION/IRRIGATOR
K110451 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 191d
Cleared Aug 26, 2011
INSTINCT JAVA SYSTEM
K111301 · NKB
Zimmer Spine
Orthopedic · 109d
Cleared Aug 26, 2011
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
K111535 · FYA
Exact Medical Manufacturing, Inc.
General Hospital · 85d
Cleared Aug 26, 2011
MONOBLOC BM SERIES
K111573 · EIH
Hass Corp.
Dental · 81d
Cleared Aug 26, 2011
COMFORTGLIDE INTERMITENT CATHETER
K112137 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 31d
Cleared Aug 26, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K112182 · PNO
Angioscore, Inc.
Cardiovascular · 29d
Cleared Aug 26, 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K112235 · MWI
Airstrip Technologies, LP
Cardiovascular · 22d
Cleared Aug 25, 2011
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
K101234 · OWF
Ventana Medical Systems, Inc.
Microbiology · 479d
Cleared Aug 25, 2011
GEMORE MUSCLE CONDITIONER
K102926 · NGX
Gemore Technology Co, Ltd.
Physical Medicine · 325d
Cleared Aug 25, 2011
DAYTONA ANTERIOR CERVICAL CAGE
K110733 · ODP
Spinenet, LLC
Orthopedic · 162d
Cleared Aug 25, 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · LCP
Siemens Healthcare Diagnostics
Chemistry · 143d
Cleared Aug 25, 2011
VESOFLOW
K110977 · JOW
Caremed Supply, Inc.
Cardiovascular · 140d
Cleared Aug 25, 2011
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
K111101 · LJT
Norfolk Medical
General Hospital · 127d
Cleared Aug 25, 2011
SONICATOR PLUS 920
K111482 · IMG
Mettler Electronics Corp.
Physical Medicine · 90d
Cleared Aug 25, 2011
XYLOS MACRO-POROUS SURGICAL MESH
K111584 · FTM
Xylos Corporation
General & Plastic Surgery · 79d