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
75505–75528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2002
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
K020739 · DQA
Bci, Inc.
Anesthesiology · 89d
Cleared Jun 03, 2002
NAVIPRO
K020764 · HAW
Kinamed, Inc.
Neurology · 88d
Cleared Jun 03, 2002
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K020776 · EFW
Coronet Group North America, LLC
Dental · 84d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · DQX
Biotronik, Inc.
Cardiovascular · 82d
Cleared Jun 03, 2002
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
K020900 · BTT
Sunrise Medical Hhg, Inc.
Anesthesiology · 75d
Cleared Jun 03, 2002
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
K020938 · JWY
Dade Microscan, Inc.
Microbiology · 73d
Cleared Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · CKG
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared Jun 03, 2002
CHARE CARIOVASCULAR PATCH
K021129 · DXZ
Chase Medical, Inc.
Cardiovascular · 56d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ
Diagnostic Products Corp.
Immunology · 45d
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