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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
51721–51744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2009
PNEUMOTHERML, MODEL: 5800
K092685 · BZQ
Salter Labs
Anesthesiology · 83d
Cleared Nov 24, 2009
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
K092761 · GEI
Bio Protech, Inc.
General & Plastic Surgery · 76d
Cleared Nov 24, 2009
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
K092773 · LOD
Tecres S.P.A.
Orthopedic · 76d
Cleared Nov 24, 2009
NBP CUFF
K092999 · DXQ
Draeger Medical AG & Co. KG
Cardiovascular · 57d
Cleared Nov 24, 2009
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
K093100 · IMC
Shenzhen Comfort Technology Co., Ltd.
Physical Medicine · 54d
Cleared Nov 24, 2009
PRO-LINE CT (BASIC TRAY) MODEL MR28036101
K093309 · LJS
Medcomp ( Medical Components)
General Hospital · 33d
Cleared Nov 24, 2009
HG III FIXTURE SYSTEM
K093352 · DZE
Hiossen, Inc.
Dental · 28d
Cleared Nov 24, 2009
NMI PICC II
K093366 · LJS
Navilyst Medical, Inc.
General Hospital · 26d
Cleared Nov 24, 2009
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
K093501 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 12d
Cleared Nov 23, 2009
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
K083770 · KNT
Coloplast A/S
Gastroenterology & Urology · 340d
Cleared Nov 23, 2009
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · LQY
J. Morita USA, Inc.
Dental · 235d
Cleared Nov 23, 2009
MODIFICATION TO IVENT 101
K092135 · CBK
Versamed Medical Systems , Ltd.
Anesthesiology · 131d
Cleared Nov 23, 2009
S. AUREUS/CNS PNA FISH, MODEL KT005
K092166 · NXX
Advandx, Inc.
Microbiology · 125d
Cleared Nov 23, 2009
VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
K092687 · NHK
A Plus Medical
Anesthesiology · 83d
Cleared Nov 23, 2009
HAIRMAX LASERCOMB
K093499 · OAP
Lexington International, LLC
General & Plastic Surgery · 11d
Cleared Nov 20, 2009
MINI LAP ELECTROCAUTERY INSTRUMENTS
K083754 · GEI
Mini Lap Technologies, Inc.
General & Plastic Surgery · 338d
Cleared Nov 20, 2009
PALOMAR LUX1540 HANDPIECE
K090195 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 297d
Cleared Nov 20, 2009
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE
K090780 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 242d
Cleared Nov 20, 2009
PROPARAFLU+ASSAY
K091053 · OOU
Prodesse, Inc.
Microbiology · 221d
Cleared Nov 20, 2009
IVD TECHNOLOGIES ACHRAB TEST KIT
K091468 · NST
Ivd Technologies
Immunology · 186d
Cleared Nov 20, 2009
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
K091795 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 156d
Cleared Nov 20, 2009
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814 · CGA
Taidoc Technology Corporation
Chemistry · 155d
Cleared Nov 20, 2009
NESSI SPACER
K091862 · NVO
Pharmacaribe
Anesthesiology · 150d
Cleared Nov 20, 2009
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01
K092050 · DHB
Phadia AB
Immunology · 136d