FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75649–75672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2002
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
K013949 · FPA
Churchill Medical Systems, Inc.
General Hospital · 117d
Cleared Mar 27, 2002
TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
K014260 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2002
NORAPAD PLAIN
K014268 · HBA
Perlei Medical, Inc.
Neurology · 90d
Cleared Mar 27, 2002
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K014272 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304 · HWC
Triage Medical, Inc.
Orthopedic · 86d
Cleared Mar 27, 2002
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006,...
K020031 · GEI
Neothermia Corp.
General & Plastic Surgery · 82d
Cleared Mar 27, 2002
PROCERA ALLCERAM BRIDGE MATERIAL
K020269 · EIH
Procera Sandvik AB
Dental · 58d
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