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
70321–70344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · HBE
Stryker Instruments
Neurology · 175d
Cleared Jan 16, 2004
LUXAFORM PLUS
K033227 · EBG
Dmg USA, Inc.
Dental · 102d
Cleared Jan 16, 2004
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
K033328 · DTL
Novosci Corp.
Cardiovascular · 92d
Cleared Jan 16, 2004
CANDELA CBEAM PULSE DYE LASER SYSTEM
K033331 · GEX
Candela Corp.
General & Plastic Surgery · 92d
Cleared Jan 16, 2004
LIGAND PLUS CONTROL LEVEL 1-3
K033344 · JJY
Consolidated Technology
Chemistry · 88d
Cleared Jan 16, 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · HSX
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 16, 2004
CANDELA VBEAM PULSE DYE LASER SYSTEM
K033461 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Jan 16, 2004
BISBLOCK
K033521 · EJK
Bisco, Inc.
Dental · 70d
Cleared Jan 16, 2004
DIAPEX
K033585 · KIF
Bisco, Inc.
Dental · 64d
Cleared Jan 16, 2004
ARTIC
K033628 · ELM
Heraeus Kulzer, Inc.
Dental · 58d
Cleared Jan 16, 2004
E.P.T. PREGNANCY TEST
K033658 · LCX
Unipath , Ltd.
Chemistry · 56d
Cleared Jan 16, 2004
POWDERED VINYL EXAMINATION GLOVES
K033692 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 53d
Cleared Jan 16, 2004
POWDER-FREE VINYL EXAMINATION GLOVES
K033693 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 53d
Cleared Jan 16, 2004
PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER
K033726 · KRA
Precision Vascular
Cardiovascular · 49d
Cleared Jan 16, 2004
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
K033877 · LYZ
One Touch Products Co., Ltd.
General Hospital · 32d
Cleared Jan 16, 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION...
K033903 · MQH
Cook Urological, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 16, 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · MQH
Cook Urological, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 16, 2004
MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · LSE
Quest Intl., Inc.
Microbiology · 29d
Cleared Jan 15, 2004
BIODHOC
K024185 · HTY
Future Medical Systems, SA
Orthopedic · 392d
Cleared Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · OLW
Aspect Medical Systems, Inc.
Neurology · 353d
Cleared Jan 15, 2004
B-SMART, MODEL B-01
K031128 · CAZ
Macosta Medical USA, LLC
Anesthesiology · 281d
Cleared Jan 15, 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108 · MBH
Aesculap, Inc.
Orthopedic · 191d
Cleared Jan 15, 2004
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
K032891 · HRX
Trans1, Inc.
Orthopedic · 120d
Cleared Jan 15, 2004
GOLD DENTAL CASTING ALLOYS
K033279 · EJT
Bego U.S.A.
Dental · 97d