FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87265–87288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 29, 1999
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
K984055 · FOZ
Sims Deltec, Inc.
General Hospital · 77d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
K984152 · DJG
Beckman Coulter, Inc.
Toxicology · 71d
Cleared Jan 29, 1999
DCI ENDOSCOPE
K984369 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 53d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · JIF
Beckman Coulter, Inc.
Chemistry · 51d
Cleared Jan 29, 1999
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
K984477 · JJY
Bio-Rad
Chemistry · 44d
Cleared Jan 29, 1999
EXHALATION VALVE
K984481 · CBP
Intersurgical, Inc.
Anesthesiology · 44d
Cleared Jan 29, 1999
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
K984626 · JJX
Bio-Rad
Chemistry · 32d
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC...
K990026 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 24d
Cleared Jan 29, 1999
AVL OMNI MODULAR ANALYZER
K990092 · CHL
Avl Scientific Corp.
Chemistry · 18d
Cleared Jan 29, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
K990125 · DSI
Hewlett-Packard GmbH
Cardiovascular · 16d
Cleared Jan 28, 1999
ASKINA HYDROCOLLOID/THIN
K973227 · KMF
B.Braun Medical, Inc.
General & Plastic Surgery · 519d
Cleared Jan 28, 1999
PHILIPS EASYGUIDE
K981480 · HAW
Philips Medical Systems, Inc.
Neurology · 279d
Cleared Jan 28, 1999
CD HORIZON SPINAL SYSTEM
K981676 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 261d
Cleared Jan 28, 1999
IS-RUBELLA IGG TEST SYSTEM
K981729 · LFX
Diamedix Corp.
Microbiology · 258d
Cleared Jan 28, 1999
COMPEED PSORIASIS DRESSING
K982493 · FRO
Coloplast Corp.
General & Plastic Surgery · 195d