Medical Device Manufacturer · US , Washington , DC

Swemed Lab International AB - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1999

Recent clearances: SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE, SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Swemed Lab International AB Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Jan 30, 2006

CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007

Obstetrics & Gynecology · 75d

Cleared Nov 05, 2002

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540

Obstetrics & Gynecology · 89d

Cleared Aug 18, 1999

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE

Obstetrics & Gynecology · 127d

Cleared Jul 19, 1999

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES

Obstetrics & Gynecology · 62d