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
69937–69960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2004
A1C-CELLULAR
K040025 · JJX
Streck Laboratories, Inc.
Chemistry · 55d
Cleared Mar 02, 2004
VIVARING MICROWAVE ABLATION PROBE
K040279 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 26d
Cleared Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · DQX
Ev3, Inc.
Cardiovascular · 19d
Cleared Mar 01, 2004
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675,...
K023684 · KWD
Vilex, Inc.
Orthopedic · 486d
Cleared Mar 01, 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961 · HRS
Inion , Ltd.
Orthopedic · 250d
Cleared Mar 01, 2004
MODIFIED SONAMET BODY COMPOSITION ANALYZER
K032610 · OAC
Life Measurement, Inc.
Obstetrics & Gynecology · 189d
Cleared Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · LON
Becton, Dickinson & CO
Microbiology · 185d
Cleared Mar 01, 2004
CLO-SURPLUSP.A.D.
K032986 · QSY
Scion Cardio-Vascular, Inc.
General & Plastic Surgery · 159d
Cleared Mar 01, 2004
ART POSTERIOR SPINAL SYSTEM
K033150 · MNI
Advanced Medical Technologies AG
Orthopedic · 153d
Cleared Mar 01, 2004
VITAL SIGNS MONITOR, PROPAQ LT
K033378 · MWI
Welch Allyn Protocol, Inc.
Cardiovascular · 131d
Cleared Mar 01, 2004
TRAPMATIC SYSTEM SET
K033616 · KNW
H.S Hospital Service S.P.A
Gastroenterology & Urology · 105d
Cleared Mar 01, 2004
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
K033617 · DRN
Vasomedical, Inc.
Cardiovascular · 104d
Cleared Mar 01, 2004
SP NEWTRON MODULE
K033764 · ELC
Satelec
Dental · 90d
Cleared Mar 01, 2004
IMALUX OCT IMAGING SYSTEM
K033783 · NQQ
Imalux Coporation
General & Plastic Surgery · 88d
Cleared Mar 01, 2004
BILOK ST SCREW
K033792 · HWC
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006,...
K033814 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 83d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · LRG
Dade Behring, Inc.
Microbiology · 73d
Cleared Mar 01, 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · HWC
Synthes (Usa)
Orthopedic · 69d
Cleared Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · KTT
Synthes (Usa)
Orthopedic · 68d
Cleared Mar 01, 2004
HERADOR EC, PF, C, H, NH, G, GG AND MP
K034049 · EJT
Heraeus Kulzer,GmbH
Dental · 62d
Cleared Mar 01, 2004
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 54d
Cleared Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · DQX
Arrow Intl., Inc.
Cardiovascular · 41d
Cleared Mar 01, 2004
LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT...
K040232 · GAT
Lsi Solutions
General & Plastic Surgery · 28d
Cleared Mar 01, 2004
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
K040278 · LYC
Novabone Products, LLC
Dental · 25d