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
75001–75024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · NBW
Roche Diagnostics Corp.
Chemistry · 28d
Cleared May 31, 2002
INPATH E2 COLLECTOR
K013258 · HHT
Molecular Diagnostics
Obstetrics & Gynecology · 242d
Cleared May 31, 2002
ENTERYX INJECTOR
K013712 · FBK
Enteric Medical Technologies
Gastroenterology & Urology · 204d
Cleared May 31, 2002
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
K020033 · HCG
Surgica Corp.
Neurology · 147d
Cleared May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · LYL
Bausch & Lomb, Incorporated
Ophthalmic · 80d
Cleared May 31, 2002
AXSYM INTACT PTH, MODEL 2G06
K020945 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 67d
Cleared May 31, 2002
SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
K021000 · LZA
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 64d
Cleared May 31, 2002
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K021379 · MNI
Ortho Tec, LLC
Orthopedic · 30d
Cleared May 31, 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED...
K021403 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared May 31, 2002
RPI REPLACEMENT PHOTOTHERAPY LIGHTS
K021531 · LBI
Replacement Parts Industries, Inc.
General Hospital · 21d
Cleared May 31, 2002
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
K021563 · JCT
Sulzer Intratherapeutics, Inc.
General & Plastic Surgery · 18d
Cleared May 31, 2002
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · MMX
Medical Device Technologies, Inc.
Cardiovascular · 15d
Cleared May 31, 2002
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
K021628 · IYN
Sonosite,Inc.
Radiology · 14d
Cleared May 30, 2002
LIGHTLANCE LASER SKIN PERFORATOR
K013021 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 265d
Cleared May 30, 2002
ROSE K POST GRAFT LENS
K013646 · HQD
Rose K International , Ltd.
Ophthalmic · 206d
Cleared May 30, 2002
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
K020673 · GEX
Wave Form Mfg., Inc.
General & Plastic Surgery · 90d
Cleared May 30, 2002
SS MATRIX
K020732 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2002
SURX RF SYSTEM
K020952 · MUK
Surx, Inc.
Gastroenterology & Urology · 66d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
MODIFICATION TO ENTEC PLASMA WANDS
K021364 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared May 30, 2002
TOESCO AQUA BLUE LED LIGHT CURING DEVICE
K021374 · EBZ
Toei Electric Co., Ltd.
Dental · 29d
Cleared May 30, 2002
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
K021587 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K021589 · DQY
Medtronic Vascular
Cardiovascular · 15d