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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69049–69072 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2004
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
K032710 · KOD
Apogee Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Jan 09, 2004
DIAMOND SETUP 2000
K032886 · LHN
K&S Assoc., Inc.
Radiology · 115d
Cleared Jan 09, 2004
PREPAIR
K033215 · KOJ
Danville Materials, Inc.
Dental · 98d
Cleared Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Jan 09, 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · HCG
Micro Therapeutics, Inc.
Neurology · 79d
Cleared Jan 09, 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Jan 09, 2004
SPIRIT 5000 CARDIAC COIL
K033490 · MOS
Usa Instruments, Inc.
Radiology · 66d
Cleared Jan 09, 2004
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218
K033830 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 08, 2004
ARIOL HER-2/NEU IHC
K031715 · NOT
Applied Imaging Corp.
Pathology · 220d
Cleared Jan 08, 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962 · JWH
Implex Corp.
Orthopedic · 197d
Cleared Jan 08, 2004
PROMOS SHOULDER
K032126 · HSD
Plus Orthopedics
Orthopedic · 182d
Cleared Jan 08, 2004
ASAP SINUSCOPE...
K032822 · EOB
Asap Endoscopic Products GmbH
Ear, Nose, Throat · 120d
Cleared Jan 08, 2004
PINNACLE REVISION SYSTEM
K033338 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Jan 08, 2004
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 59d
Cleared Jan 08, 2004
CO2 CALIBRATOR/DILUENT
K033643 · JIT
Bayer Healthcare, Diagnostics Division
Chemistry · 49d
Cleared Jan 08, 2004
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 45d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971,...
K033818 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Jan 08, 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · MQP
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · NBW
Abbott Laboratories
Chemistry · 28d
Cleared Jan 08, 2004
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987 · DTM
Dideco S.P.A.
Cardiovascular · 16d
Cleared Jan 08, 2004
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K034003 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jan 08, 2004
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
K034013 · LKJ
Corgenix, Inc.
Immunology · 15d
Cleared Jan 07, 2004
OSTEOMED ORTHODONTIC SCREW SYSTEM
K031936 · DZE
Osteomed LP
Dental · 198d