12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZENITH PEDICLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POGS, MODEL 65/130
FDA 510(k)
FDA Class 2
·Anesthesiology
TPRLOC COCR CMTD STM T1 12.5MM
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 23, 2026
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
FDA Enforcement
Class II
·Ongoing·ASO LLC·August 24, 2022
SL PLUS STANDARD
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code JDH·October 22, 2014
MINILINK TRANSMITTER
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 27, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·August 5, 2011
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
FDA Recall
Open, Classified
·ASO LLC·Product code FQM·June 22, 2022
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 8, 2026