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
145681–145704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340 · CIX
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Feb 19, 1986
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447 · KKX
Standard Textile Co., Inc.
General Hospital · 15d
Cleared Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · JJX
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 19, 1986
NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE
K860492 · FRN
Nordisk Infuser System
General Hospital · 16d
Cleared Feb 19, 1986
RELIANCE MODEL 200 PODIATRY CHAIR
K860519 · LGX
F. & F. Koenigkramer
General Hospital · 8d
Cleared Feb 18, 1986
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
K850861 · DXT
Medical Components, Inc.
Cardiovascular · 354d
Cleared Feb 18, 1986
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
K853730 · MBV
Protek, Inc.
Orthopedic · 165d
Cleared Feb 18, 1986
MONOPOLAR INJECTION NEEDLE ELECTRODE
K854793 · HLW
Oculinum, Inc.
Ophthalmic · 75d
Cleared Feb 18, 1986
OMKNEE SYSTEM
K854883 · JWH
Orthomet, Inc.
Orthopedic · 74d
Cleared Feb 18, 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089 · DQX
Dlp, Inc.
Cardiovascular · 60d
Cleared Feb 18, 1986
S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
K855095 · LLO
Surgical Laser Technologies, Inc.
Anesthesiology · 57d
Cleared Feb 18, 1986
CIRIBART GYUDUBG CATGETER
K855103 · DQO
Mansfield Scientific, Inc.
Cardiovascular · 57d
Cleared Feb 18, 1986
THARIES FIBER
K855148
Zimmer, Inc.
Orthopedic · 54d
Cleared Feb 18, 1986
MAGNESIUM REAGENT SET
K855190 · JGJ
Technostics Intl.
Chemistry · 54d
Cleared Feb 18, 1986
SG-066 OXYGEN ENRICHMENT KIT
K860077 · BTL
Instrumentation Industries, Inc.
Anesthesiology · 41d
Cleared Feb 18, 1986
MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING
K860198 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 27d
Cleared Feb 18, 1986
CANNULA BAND
K860261 · CAT
T. G. & E. Medical
Anesthesiology · 25d
Cleared Feb 14, 1986
LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE
K853708 · KAE
Downs Surgical , Ltd.
Ear, Nose, Throat · 163d
Cleared Feb 14, 1986
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM
K854070 · CBK
Puritan Bennett Corp.
Anesthesiology · 133d
Cleared Feb 14, 1986
TOP SUN
K854750 · FTC
Werner Schott Elektrogerate
General & Plastic Surgery · 80d
Cleared Feb 14, 1986
MINIPAC PERSONAL TOUCH (TM)
K854761 · GZJ
Medical Devices, Inc.
Neurology · 79d
Cleared Feb 14, 1986
NI-PACER 1
K854853 · DRO
Associated Medical Devices, Inc.
Cardiovascular · 71d
Cleared Feb 14, 1986
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
K860155 · FKO
Medical Components, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 13, 1986
ESPE NIMETIC-GRIP
K844844 · DYH
Espe GmbH (Us)
Dental · 427d