Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78841–78864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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