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

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176,076 results
78649–78672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2001
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
K012124 · GAP
Johnson & Johnson Medical (China) , Ltd.
General & Plastic Surgery · 75d
Cleared Sep 19, 2001
LOWSLEY SUPRAPUBIC TRACTOR
K012153 · KOB
Circon Video
Gastroenterology & Urology · 70d
Cleared Sep 19, 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154 · LNH
Aurora Imaging Technology, Inc.
Radiology · 70d
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · KPR
Nucletron Corp.
Radiology · 70d
Cleared Sep 19, 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · GAT
Aesculap, Inc.
General & Plastic Surgery · 68d
Cleared Sep 19, 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · CDQ
Wiener Laboratories Saic
Chemistry · 63d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · KXT
Diagnostic Products Corp.
Toxicology · 61d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · MAI
Bionx Implants, Inc.
Orthopedic · 57d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371 · DDG
Roche Diagnostics Corp.
Immunology · 55d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · DDG
Roche Diagnostics Corp.
Immunology · 54d
Cleared Sep 19, 2001
BIFURCATED VACCINATING NEEDLE
K012515 · SCL
Precision Medical Products, Inc.
General Hospital · 44d
Cleared Sep 19, 2001
M71 POWER WHEELCHAIR
K012927 · ITI
Invacare Corp.
Physical Medicine · 19d
Cleared Sep 18, 2001
HARRISON HAND HELD ADJUSTING INSTRUMENT
K010851 · LXM
Harrison Cbp Seminars
Physical Medicine · 181d
Cleared Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · LCP
Tosoh Medics, Inc.
Hematology · 131d
Cleared Sep 18, 2001
HANDPIECE SHEATH-MODEL #A910
K011929 · GEI
Aaron Medical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 18, 2001
DS30 HCY BLOOD COLLECTION TUBES
K012152 · GIM
Drew Scientific , Ltd.
Chemistry · 69d
Cleared Sep 18, 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · KKX
Advance Medical Designs, Inc.
General Hospital · 68d
Cleared Sep 18, 2001
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351 · LSL
Becton, Dickinson & CO
Microbiology · 55d
Cleared Sep 18, 2001
MACROPORE FX, PS, NS, LP
K012413 · JEY
Macropore Biosurgery, Inc.
Dental · 50d
Cleared Sep 18, 2001
DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K012711 · LYZ
Shijiazhuang Brilliance Plastic Co.,...
General Hospital · 35d
Cleared Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2,...
K012722 · GGN
Bio-Rad
Hematology · 34d
Cleared Sep 18, 2001
HEMOSIL RECOMBI PLASTIN
K012768 · GJS
Instrumentation Laboratory CO
Hematology · 32d
Cleared Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · KPS
GE Medical Systems
Radiology · 29d
Cleared Sep 18, 2001
MP3CF ELECTRIC WHEELCHAIR
K012802 · ITI
Merits Health Products., Inc.
Physical Medicine · 28d