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
94345–94368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1997
SOLARO 33
K970045 · EJS
Metalor Dental USA Corp.
Dental · 58d
Cleared Mar 05, 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 57d
Cleared Mar 05, 1997
BIOPSY TRAY
K970152 · FRG
Medcare Medical Group, Inc.
General Hospital · 48d
Cleared Mar 04, 1997
EZTEST-GAS
K930683 · FRC
Sgm Biomedical, Inc.
General Hospital · 1483d
Cleared Mar 04, 1997
AUTOSTATTMII ANTI-DSDNA
K952567 · LRM
Cogent Diagnotics , Ltd.
Immunology · 638d
Cleared Mar 04, 1997
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
K954676 · KOC
Nissho Corp.
Gastroenterology & Urology · 511d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661 · DXG
Abbott Laboratories
Cardiovascular · 308d
Cleared Mar 04, 1997
STRYKER ENCORE STERILIZER
K962755 · FLE
Stryker Corp.
General Hospital · 231d
Cleared Mar 04, 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257 · LJS
Arrow Intl., Inc.
General Hospital · 197d
Cleared Mar 04, 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · DZE
Dentsply Intl.
Dental · 146d
Cleared Mar 04, 1997
FLEXILOG 3000
K964589 · KLA
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 109d
Cleared Mar 04, 1997
MD-1835
K964806 · IXL
Fischer Imaging Corp.
Radiology · 95d
Cleared Mar 04, 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855 · HOZ
Shippert Medical Technologies Corp.
Ophthalmic · 90d
Cleared Mar 04, 1997
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY...
K964879 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 89d
Cleared Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Mar 04, 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · FMF
Vascular Logics, Inc.
General Hospital · 77d
Cleared Mar 04, 1997
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
K965059 · BTA
Thomas Industries
General & Plastic Surgery · 76d
Cleared Mar 04, 1997
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
K965176 · OCZ
Pilling Weck Group
Gastroenterology & Urology · 70d
Cleared Mar 04, 1997
IMAGER TORQUE CATHETER
K965229 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Mar 04, 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · ITX
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Mar 04, 1997
JAMES ALEX SUNGLASSES
K970101 · HQY
D&K Stores, Inc.
Ophthalmic · 50d
Cleared Mar 04, 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW...
K970105 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 50d
Cleared Mar 04, 1997
NOAH MONITORING ELECTRODE SYSTEM
K970125 · DRX
Contour Medical Technology, Inc.
Cardiovascular · 49d
Cleared Mar 03, 1997
SYNERMED ISE REAGENTS
K962479 · CGZ
Synermed, Inc.
Chemistry · 250d