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
86737–86760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1999
AESCULAP XENON LIGHT SOURCE
K984124 · FSS
Aesculap, Inc.
General & Plastic Surgery · 75d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182 · DSY
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183 · DYF
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Feb 01, 1999
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER,...
K984233 · CAC
Fresenius Hemotechnology, Inc.
Anesthesiology · 68d
Cleared Feb 01, 1999
THE GOLDEN TIP ELECTRO-SURGICAL PROBE
K984275 · GEI
Amada Surgical
General & Plastic Surgery · 63d
Cleared Feb 01, 1999
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT
K984291 · JWH
Implex Corp.
Orthopedic · 62d
Cleared Feb 01, 1999
ZETA MULTIZONE LOCKING NAIL SYSTEM
K984305 · HSB
Howmedica, Inc.
Orthopedic · 61d
Cleared Feb 01, 1999
SHEER THIN
K984488 · HIS
Twe Companies, Inc.
Obstetrics & Gynecology · 46d
Cleared Feb 01, 1999
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K990095 · MBI
Influence, Inc.
Orthopedic · 20d
Cleared Feb 01, 1999
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
K990120 · HSB
Depuy Ace Medical Co.
Orthopedic · 19d
Cleared Feb 01, 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · MNI
Osteonics Corp.
Orthopedic · 13d
Cleared Jan 29, 1999
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982328 · CJO
Bayer Corp.
Chemistry · 211d
Cleared Jan 29, 1999
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
K982346 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 207d
Cleared Jan 29, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
K982947 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 161d
Cleared Jan 29, 1999
POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
K983029 · ELC
Tpc Advanced Technology, Inc.
Dental · 151d
Cleared Jan 29, 1999
APOLIPOPROTEIN A1
K983289 · DER
Abbott Laboratories
Immunology · 133d
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX...
K983674 · JMM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 101d
Cleared Jan 29, 1999
SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
K983858 · MIA
Sims Portex, Inc.
Anesthesiology · 88d
Cleared Jan 29, 1999
OPMI TWINER SURGICAL MICROSCOPE
K983868 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 88d
Cleared Jan 29, 1999
CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
K983878 · EOQ
E. Benson Hood Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Jan 29, 1999
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
K983885 · JEY
Howmedica, Inc.
Dental · 88d
Cleared Jan 29, 1999
VENOMETER
K983900 · JOM
Advanced Medical Technology , Ltd.
Cardiovascular · 87d
Cleared Jan 29, 1999
AMPLAID A315 AND A319
K983915 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 86d
Cleared Jan 29, 1999
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · EJR
Dentsply Intl.
Dental · 84d