Medical Device Manufacturer · US , Fall River , MA

Genzyme Biosurgery - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2002
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genzyme Biosurgery General & Plastic Surgery ✕
3 devices
1-3 of 3
Cleared Mar 27, 2003
MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K030212 · NEW
General & Plastic Surgery · 65d
Cleared Nov 25, 2002
RADLITE TISSUE RETRACTOR SYSTEM
K022989 · FSW
General & Plastic Surgery · 77d
Cleared Aug 20, 2002
SAPH-LOOP LIGATING LOOP
K022410 · GAT
General & Plastic Surgery · 27d
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All4 General & Plastic Surgery 3 Anesthesiology 1