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
76777–76800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020322 · LON
Becton, Dickinson & CO
Microbiology · 71d
Cleared Mar 27, 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611 · HRS
Spinal Concepts, Inc.
Orthopedic · 30d
Cleared Mar 27, 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 23d
Cleared Mar 27, 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · LOJ
Bayer Corp.
Immunology · 15d
Cleared Mar 27, 2002
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K020881 · FRN
Science Incorporated
General Hospital · 9d
Cleared Mar 26, 2002
M3 (MIRCO-MULTILEAF COLLIMATOR
K004022 · IYE
Brainlab AG
Radiology · 454d
Cleared Mar 26, 2002
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT...
K010131 · KDI
Aksys, Ltd.
Gastroenterology & Urology · 434d
Cleared Mar 26, 2002
FLOWTRON UNIVERSAL, MODEL AC600
K010744 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 378d
Cleared Mar 26, 2002
ACCESS SEQUESTRATION SYSTEM
K012406 · CAC
Interpore Cross Intl.
Anesthesiology · 239d
Cleared Mar 26, 2002
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
K012852 · KYF
Optonol, Ltd.
Ophthalmic · 214d
Cleared Mar 26, 2002
MOONRAY MOBILE C-ARM
K013426 · OXO
Simad S.R.L.
Radiology · 161d
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · MRG
DiaSorin, Inc.
Chemistry · 110d
Cleared Mar 26, 2002
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES
K014236 · GEX
Clinicon Corp.
General & Plastic Surgery · 90d
Cleared Mar 26, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL...
K014243 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Mar 26, 2002
NTERO HOTROD SYSTEM
K014251 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2002
DERMACHILLER 4
K014253 · GEX
Paradigm Trex, LLC
General & Plastic Surgery · 90d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Mar 26, 2002
COSMED QUARK C12/QUARK T12
K014262 · DPS
Cosmed Srl
Cardiovascular · 89d
Cleared Mar 26, 2002
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
K014303 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Mar 26, 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K020479 · DQA
Datex-Ohmeda
Anesthesiology · 41d
Cleared Mar 26, 2002
CARD IQ ANALYSIS II
K020796 · JAK
GE Medical Systems
Radiology · 14d
Cleared Mar 26, 2002
I-FLOW ELASTOMERIC PUMP
K020862 · MEB
I-Flow Corp.
General Hospital · 8d
Cleared Mar 25, 2002
3M ATTEST 290 AUTO-READER
K004009 · FRC
3M Company
General Hospital · 454d