11 results
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17ms
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Sources: EU EUDAMED, US FDA
KLIGLER IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Legacy™2 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307101611·Ø3.2 x 13 Platform 3.0mmD
BONDEK
FDA UDI
TELEFLEX INCORPORATED·04026704603930·Bondek Green Braided-Coated Size 0 48" TC-43 Ne...
STARCERAM
FDA 510(k)
FDA Class 2
·Dental
CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
FDA 510(k)
FDA Class 1
·Dental
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 15, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 9, 2010
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·May 14, 2014
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·April 2, 2014