12 results
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29ms
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Sources: EU EUDAMED, US FDA
THE CAROLINA ROCKER
FDA 510(k)
FDA Class 1
·Physical Medicine
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601013·MTO GLEN AIMER ARM 7MM OFFSET TIP EXTEND
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221111319·3M™ Unitek™ Bracket Positioning Gauge Three, 90...
MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
FDA 510(k)
FDA Class 2
·Orthopedic
BARIREP
FDA 510(k)
FDA Unclassified
·Unknown
SNAP-RING FOR 52MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·December 4, 2007
TRULIANT TIB IMP PS INSERT SZ 5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 10, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 1, 2024
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·June 27, 2014
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 9, 2010
HALL STERUM
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code KFK·December 18, 2012
Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009