Smith & Nephew Inc., Endoscopy Div.
Smith & Nephew Inc., Endoscopy Div. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2024, with 7 FDA device recalls on record.
Top product codes for Smith & Nephew Inc., Endoscopy Div.
FDA recalls by Smith & Nephew Inc., Endoscopy Div.
- Z-0156-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Z-0158-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Z-0155-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Z-0157-2016 — Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Z-0818-2016 — High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
- Z-0700-2016 — Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
- Z-0699-2016 — Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Smith & Nephew Inc., Endoscopy Div.
- K242631 — REGENETEN Bioinductive Implant
- K111843 — ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
- K102544 — SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
- K092551 — SMITH & NEPHEW INSTRUMENT TRAYS
- K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
- K093943 — BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
- K093897 — SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
- K073551 — SMITH & NEPHEW INSTRUMENT TRAYS
- K080358 — PLLA, HA SCREW
- K063726 — PLC SUTURE ANCHOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.