FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121705–121728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1991
PONTOR 4 CF
K911541 · EJT
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
PONTOR 2
K911542 · EJT
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
SOLARO 3
K911543 · EJT
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
SOLARO 4
K911544 · EJT
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 26, 1991
ARRHYTHMIA 9215
K900366 · DSI
S & W Medico Teknik
Cardiovascular · 455d
Cleared Apr 26, 1991
SERVO VENTILATOR 300
K902859 · CBK
Siemens Life Support Systems
Anesthesiology · 301d
Cleared Apr 26, 1991
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
K904943 · BZT
Arzco Medical Electronics, Inc.
Anesthesiology · 176d
Cleared Apr 26, 1991
ELECTROSONOGRAM ESG-1
K905449 · NFQ
Myo-Tronics, Inc.
Dental · 142d
Cleared Apr 26, 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520 · BZQ
Synectics-Dantec
Anesthesiology · 140d
Cleared Apr 26, 1991
INTIMAX THROMBECTOMY CATHETER
K910372 · DXE
Applied Vascular Devices, Inc.
Cardiovascular · 87d
Cleared Apr 26, 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490 · DSI
Hewlett-Packard Co.
Cardiovascular · 80d
Cleared Apr 26, 1991
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2
K910597 · HQY
Radix Group Intl.
Ophthalmic · 73d
Cleared Apr 26, 1991
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
K910973 · HQE
Surgical Technologies, Inc.
Ophthalmic · 50d
Cleared Apr 25, 1991
COMPAC(TM) DIODE LASERS
K904699 · HQF
Hgm Medical Laser Systems, Inc.
Ophthalmic · 191d
Cleared Apr 25, 1991
CONSUMER SENSORY PRODUCTS BIO-LOG 8000
K904955 · FLL
Consumer Sensory Products, Inc.
General Hospital · 171d
Cleared Apr 25, 1991
PHARM-ASSIST
K905116 · LHI
Excel Medical, Inc.
General Hospital · 163d
Cleared Apr 25, 1991
ENDOSCOPE AND ACCESSORIES
K905117 · GCI
Northgate Technologies, Inc.
General & Plastic Surgery · 163d
Cleared Apr 25, 1991
SPLASH GUARD
K905173 · KYZ
E.M. Adams
General Hospital · 160d
Cleared Apr 25, 1991
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
K905470 · EIE
Elastomade Accessories Sdn Bhd
Dental · 140d
Cleared Apr 25, 1991
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
K910214 · FAE
American Medical Corp.
Gastroenterology & Urology · 98d
Cleared Apr 25, 1991
SURGICAL GOWNS, EXTRA-LARGE SIZE
K910410 · FYC
Dawn of Hope Development Center
General Hospital · 86d
Cleared Apr 25, 1991
WILSON-COOK DISPOSABLE BIOPSY FORCEPS
K910656 · FLC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 25, 1991
DISPOSABLE ELECTROSURGICAL BLADE
K910779 · GEI
Conmedcorp
General & Plastic Surgery · 59d
Cleared Apr 25, 1991
PLASTIC (VINYL) EXAMINATION GLOVES
K910879 · LYZ
Siamount Plastic Corporation , Ltd.
General Hospital · 55d