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
78241–78264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561 · JJX
Ortho-Clinical Diagnostics
Microbiology · 21d
Cleared Aug 29, 2001
E-SCAN MRI SYSTEM
K012728 · MOS
Biosound Esaote, Inc.
Radiology · 14d
Cleared Aug 28, 2001
POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
K002172 · GAT
Xiros Plc
General & Plastic Surgery · 405d
Cleared Aug 28, 2001
ACCU-PULSE TENS UNIT
K010203 · GZJ
Sadler Electronics
Neurology · 218d
Cleared Aug 28, 2001
ORTELIUS 800
K011827 · KQX
Orthoscan , Ltd.
Neurology · 77d
Cleared Aug 28, 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · CAW
Merits Health Products., Inc.
Anesthesiology · 77d
Cleared Aug 28, 2001
SNIPER ELITE MODEL-OR-E3872XX SERIES
K011905 · DQX
Maxxim Medical
Cardiovascular · 70d
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937 · FOZ
Micro Therapeutics, Inc.
General Hospital · 68d
Cleared Aug 28, 2001
BI-PHASIC INFILTRATOR
K012044 · FRN
Reliance Medical Corp.
General Hospital · 60d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · DQY
Medtronic Vascular
Cardiovascular · 56d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130 · DQY
Medtronic Vascular
Cardiovascular · 50d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · DYG
Medtronic Vascular
Cardiovascular · 43d
Cleared Aug 28, 2001
WH ACCU TEST PREGNANCY TEST
K012284 · JHI
W.H.P.M., Inc.
Chemistry · 39d
Cleared Aug 28, 2001
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE...
K012431 · JJY
Bionostics, Inc.
Chemistry · 28d
Cleared Aug 27, 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM,...
K002328 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 391d