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
77713–77736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2001
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
K011745 · ITI
Transworld Mobility Distribution, LLC
Physical Medicine · 85d
Cleared Aug 30, 2001
PALOMAR LC 100 DIODE LASER
K011747 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Aug 30, 2001
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
K011769 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 84d
Cleared Aug 30, 2001
MICRO TARGETING DRIVE SYSTEM
K011775 · HAW
FHC, Inc.
Neurology · 84d
Cleared Aug 30, 2001
INSIGHT GENESIS
K011983 · HCC
Fasstech
Neurology · 65d
Cleared Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
K012169 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 49d
Cleared Aug 30, 2001
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
K012253 · IYO
Aloka Co., Ltd.
Radiology · 43d
Cleared Aug 30, 2001
OPTIBOND 2
K012322 · KLE
Sybron Dental Specialties, Inc.
Dental · 38d
Cleared Aug 30, 2001
TRANSLUX ENERGY
K012341 · EBZ
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Aug 30, 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488 · GEI
Endius, Inc.
General & Plastic Surgery · 27d
Cleared Aug 30, 2001
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH...
K012489 · DYB
Appriva Medical, Inc.
Cardiovascular · 27d
Cleared Aug 30, 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY...
K012507 · LPH
Implex Corp.
Orthopedic · 24d
Cleared Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY...
K012593 · LBR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 20d
Cleared Aug 30, 2001
LIQUISPX LIQUID LIPID CONTROL
K012855 · JJY
Clinical Controls Division
Chemistry · 6d
Cleared Aug 29, 2001
VULCAN TAC PROBES, MODEL 911XXX
K003198 · HRX
Oratec Interventions, Inc.
Orthopedic · 321d
Cleared Aug 29, 2001
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
K003555 · MEG
Spectrum Biotech, Inc.
General Hospital · 285d
Cleared Aug 29, 2001
VIEWSTATION
K011694 · LLZ
Impac Medical Systems, Inc.
Radiology · 90d
Cleared Aug 29, 2001
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH...
K011703 · GEX
Lumenis
General & Plastic Surgery · 89d
Cleared Aug 29, 2001
ELK LASER IMAGER, MODEL EL-DRY 4000
K011949 · LMC
Nishimoto Sangyo Co., Ltd.
Radiology · 69d
Cleared Aug 29, 2001
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · FMI
Becton, Dickinson & CO
General Hospital · 64d
Cleared Aug 29, 2001
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
K012080 · IYN
Aloka Co., Ltd.
Radiology · 57d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared Aug 29, 2001
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS...
K012513 · JJY
Bio-Rad
Chemistry · 23d