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
60985–61008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2006
MISSION TRINITY B
K062674 · JJY
Diamond Diagnostics, Inc.
Chemistry · 84d
Cleared Dec 01, 2006
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K062719 · GEX
Laserscope
General & Plastic Surgery · 80d
Cleared Dec 01, 2006
CONSERVE FEMORAL RESURFACING COMPONENT
K062960 · KXA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Dec 01, 2006
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
K063012 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 60d
Cleared Dec 01, 2006
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
K063013 · MSH
Aearo Company
General Hospital · 60d
Cleared Dec 01, 2006
LINA POWERBLADE, MODEL...
K063025 · GEI
Lina Medical Aps
General & Plastic Surgery · 60d
Cleared Dec 01, 2006
HKBOND 2006
K063062 · KLE
Heraeus Kulzer, Inc.
Dental · 57d
Cleared Dec 01, 2006
REVLITE Q-SWITCHED ND:YAG LASER
K063112 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 51d
Cleared Dec 01, 2006
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
K063220 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 38d
Cleared Dec 01, 2006
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 22d
Cleared Dec 01, 2006
MEDICAN ALPHA
K063469 · FOZ
Eastern Medikit , Ltd.
General Hospital · 15d
Cleared Dec 01, 2006
LOGIC LAPAROSCOPIC SCISSORS
K063485 · GEI
Surgical Innovations Plc
General & Plastic Surgery · 14d
Cleared Dec 01, 2006
DYNAMIC GAS SCAVENGING SYSTEM (DGSS)
K063519 · CBN
Anesthetic Gas Reclamation, LLC
Anesthesiology · 10d
Cleared Dec 01, 2006
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT...
K063538 · GEI
Arthrocare Corp.
General & Plastic Surgery · 7d
Cleared Nov 30, 2006
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
K052519 · NOP
Spectral Diagnostics, Inc.
Microbiology · 442d
Cleared Nov 30, 2006
VASOPRESS DVT SYSTEM, MODEL VP500D
K061814 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 156d
Cleared Nov 30, 2006
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140,...
K062271 · MHX
Philips Medical Systems
Cardiovascular · 115d
Cleared Nov 30, 2006
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
K062313 · LYY
Pt Mahakarya Inti Buana
General Hospital · 114d
Cleared Nov 30, 2006
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
K062340 · LYK
Cardio-Optics, Inc.
Cardiovascular · 112d
Cleared Nov 30, 2006
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM
K062589 · GEX
Inolase 2002, Ltd.
General & Plastic Surgery · 90d
Cleared Nov 30, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 83d
Cleared Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Nov 30, 2006
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
K062833 · FCF
Vidacare Corporation
Gastroenterology & Urology · 70d
Cleared Nov 30, 2006
RAPID STRAND RX
K063177 · KXK
Oncura, Inc.
Radiology · 42d