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
76489–76512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2002
LAP DISC 120 X 120MM X 2CM #LD111
K020307 · GCJ
Hakko Shoji Co., Ltd.
General & Plastic Surgery · 87d
Cleared Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · LPL
CooperVision, Inc.
Ophthalmic · 79d
Cleared Apr 26, 2002
FUSION 7D
K020546 · LLZ
Mirada Solutions , Ltd.
Radiology · 66d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · JWY
Dade Microscan, Inc.
Microbiology · 65d
Cleared Apr 26, 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · DYH
GC America, Inc.
Dental · 64d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · LTT
Dade Microscan, Inc.
Microbiology · 59d
Cleared Apr 26, 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
K020690 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 53d
Cleared Apr 26, 2002
SIIS#1 TISSUE SUSPENSION SYSTEM
K020705 · OTN
Tag Medical Products
Gastroenterology & Urology · 53d
Cleared Apr 26, 2002
SERRALSILK
K020901 · GAP
Serral, S.A. DE C.V.
General & Plastic Surgery · 37d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · JDI
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Apr 26, 2002
ACIST PLUS 4 ANGIOGRAPHIC CATHETER
K021015 · DQO
Acist Medical Systems
Cardiovascular · 28d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
bioMerieux, Inc.
Microbiology · 18d
Cleared Apr 26, 2002
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
K021197 · FMF
Hosuk Co., Ltd.
General Hospital · 10d
Cleared Apr 25, 2002
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
K010128 · DYB
Cook Vascular, Inc.
Cardiovascular · 464d
Cleared Apr 25, 2002
PVS BASIC 2
K013310 · HQD
Paragon Vision Sciences
Ophthalmic · 203d
Cleared Apr 25, 2002
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517 · DQY
Medtronic Vascular
Cardiovascular · 185d
Cleared Apr 25, 2002
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 135d
Cleared Apr 25, 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING...
K014168 · IYN
Biosound Esaote, Inc.
Radiology · 127d
Cleared Apr 25, 2002
ISAAC 1.5 T MR SYSTEM
K020268 · LNH
Chi, Inc.
Radiology · 90d
Cleared Apr 25, 2002
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
K020333 · DXT
Atrion Medical Products, Inc.
Cardiovascular · 84d
Cleared Apr 25, 2002
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · DPS
Philips Medical Systems, Inc.
Cardiovascular · 51d
Cleared Apr 25, 2002
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF...
K021005 · FPA
Sterling Medivations, Inc.
General Hospital · 28d
Cleared Apr 25, 2002
S2 FEMORAL NAIL
K021026 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 25, 2002
S2 TIBIAL NAIL
K021027 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d