FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
129337–129360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1989
TENZCARE STIMULATOR 6890
K891992 · GZJ
3M Company
Neurology · 198d
Cleared Oct 12, 1989
COUPLANT WARMING DEVICE
K893225 · IYO
Echo Ultrasound
Radiology · 168d
Cleared Oct 12, 1989
KORN MANDIBULAR ADVANCER
K893482 · EJF
American Orthodontics
Dental · 161d
Cleared Oct 12, 1989
HEMO-ALERT
K893830 · DQO
Koregon Enterprise, Inc.
Cardiovascular · 141d
Cleared Oct 12, 1989
P POLYMER
K893990 · LDD
Pace West
Cardiovascular · 129d
Cleared Oct 12, 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · DXO
Ppg Industries, Inc.
Cardiovascular · 111d
Cleared Oct 12, 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Oct 12, 1989
APDYNE PHENOL APPLICATOR KIT
K894369 · KCJ
Apdyne Medical Co.
Ear, Nose, Throat · 90d
Cleared Oct 12, 1989
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
K894389 · GGX
Catachem, Inc.
Chemistry · 87d
Cleared Oct 12, 1989
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
K894462 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 86d
Cleared Oct 12, 1989
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
K894476 · CJY
Catachem, Inc.
Chemistry · 86d
Cleared Oct 12, 1989
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · DWX
Olympus Corp.
Cardiovascular · 85d
Cleared Oct 12, 1989
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540 · DXH
Physio-Control Corp.
Cardiovascular · 84d
Cleared Oct 12, 1989
CLEARPLAN EASY
K894579 · CEP
Unipath , Ltd.
Chemistry · 80d
Cleared Oct 12, 1989
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · DXE
Shiley, Inc.
Cardiovascular · 79d
Cleared Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · LZO
Osteonics Corp.
Orthopedic · 80d
Cleared Oct 12, 1989
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · DSY
Medtronic Vascular
Cardiovascular · 78d
Cleared Oct 12, 1989
PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K894747 · DXO
Endosonics Corp.
Cardiovascular · 78d
Cleared Oct 12, 1989
CARE 5000 SYSTEM
K894858 · DSI
Care Systems, Inc.
Cardiovascular · 73d
Cleared Oct 12, 1989
PERLIDENT
K894933 · EJR
Germiphene Corp.
Dental · 70d
Cleared Oct 12, 1989
DISPOSABLE PLASTIC VAGINAL SPECULA
K894957 · HIB
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 66d
Cleared Oct 12, 1989
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · DTD
Medtronic Vascular
Cardiovascular · 66d
Cleared Oct 12, 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · CFT
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Oct 12, 1989
ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
K895032 · LDD
Zmi Corp.
Cardiovascular · 65d