Medical Device Manufacturer · US , Beverly , MA

Axya Medical, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1998

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Axya Medical, Inc. General & Plastic Surgery ✕

10 devices

1-10 of 10

Cleared Jul 11, 2007

AXYA SUTURE WELDING SYSTEM AND KIT

General & Plastic Surgery · 166d

Cleared Dec 04, 2006

TUFFLEX POLYESTER SUTURE

General & Plastic Surgery · 45d

Cleared Sep 01, 2006

AXYAFLEX POLYESTER SUTURE

General & Plastic Surgery · 221d

Cleared Sep 10, 2002

AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM

General & Plastic Surgery · 90d

Cleared Oct 06, 2000

SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)

General & Plastic Surgery · 50d

Cleared Aug 24, 2000

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

General & Plastic Surgery · 15d

Cleared Jan 13, 2000

MODIFICATION TO BONE ANCHOR AND KIT (BAK)

General & Plastic Surgery · 22d

Cleared Sep 22, 1999

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

General & Plastic Surgery · 64d

Cleared Nov 27, 1998

SUTURE WELDING SYSTEM AND KIT (SWK)

General & Plastic Surgery · 84d

Cleared May 11, 1998

AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)

General & Plastic Surgery · 55d