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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118609–118632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1991
CAVITY VARNISH PRODUCT
K914324 · EMA
Confi-Dental Products Co.
Dental · 92d
Cleared Dec 27, 1991
ELISA RUBELLA IGM
K914420 · LFX
Sclavo, Inc.
Microbiology · 85d
Cleared Dec 27, 1991
STOMA MEASURING DEVICE
K914482 · FPD
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 80d
Cleared Dec 27, 1991
SIGMA PROCEDURE NO. 333-UV
K914777 · DML
Sigma Diagnostics, Inc.
Toxicology · 65d
Cleared Dec 27, 1991
VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM
K915094 · LMB
Vortech Data, Inc.
Radiology · 45d
Cleared Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
K915112 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Dec 27, 1991
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE
K915118 · HQC
Ipax, Inc.
Ophthalmic · 44d
Cleared Dec 27, 1991
TEF/PLATINUM PISTON
K915120 · ETB
River Medical, Inc.
Ear, Nose, Throat · 44d
Cleared Dec 27, 1991
MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP
K915353 · EIA
Matrix Medica, Inc.
Dental · 31d
Cleared Dec 24, 1991
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K912384 · HQE
Nidek, Inc.
Ophthalmic · 210d
Cleared Dec 24, 1991
LULMITEX NEONATAL TRANSILLUMINATOR
K912747 · HJN
Lumitex, Inc.
Ophthalmic · 186d
Cleared Dec 24, 1991
LIMA 28MM CERAMIC HEAD, MODIFICATION
K912985 · LZO
Turnkey Intergration USA, Inc.
Orthopedic · 175d
Cleared Dec 24, 1991
CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH
K914316 · LYY
Medi-Flex Hospital Products, Inc.
General Hospital · 89d
Cleared Dec 23, 1991
SURGICAL OBTURATOR WITH SEAL
K911730 · GCJ
Applied Vascular Devices, Inc.
General & Plastic Surgery · 250d
Cleared Dec 23, 1991
MODEL HD-207 BIDIRECTIONAL VELOCITY METER
K912409 · JOP
Koven and Assoc., Inc.
Radiology · 206d
Cleared Dec 23, 1991
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · HLI
Carl Zeiss, Inc.
Ophthalmic · 194d
Cleared Dec 23, 1991
COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE
K912994 · EBZ
Wilde-USA, Inc.
Dental · 168d
Cleared Dec 23, 1991
TEFLON COATED ELECTRODES/ELECTRODES HANDLES
K913108 · GEI
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 164d
Cleared Dec 23, 1991
PATIENT EXAMINATION GLOVES
K914284 · LYY
K-International Exports Pvt. , Ltd.
General Hospital · 90d
Cleared Dec 23, 1991
SURGI LIGHT NON-CONTACT FIBERS
K914396 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 83d
Cleared Dec 23, 1991
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433 · GZB
Medtronic Vascular
Neurology · 80d
Cleared Dec 23, 1991
ADVANCE(R) PREGNANCY TEST
K914990 · LCX
Ortho Pharmaceutical Corp.
Chemistry · 46d
Cleared Dec 23, 1991
TEF/WIRE PISTON
K915121 · ETB
River Medical, Inc.
Ear, Nose, Throat · 40d
Cleared Dec 20, 1991
VEOLAR VENTILATOR
K901448 · CBK
Hamilton Medical, Inc.
Anesthesiology · 632d