30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYRIAN
FDA 510(k)
FDA Class 2
·Radiology
SCFE Screw
FDA UDI
ORTHOPEDIATRICS CORP.·00841132116463·7.0MM BONE SCREW WASHER
Key Surgical Indicator Dot Case Locking Tags
FDA UDI
KEY SURGICAL, INC.·00849771031031·Case Locking Tag, Orange, Steam Indicator Dot. ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702542646·Elvarex Forte 3/Knee High/Profile-Slant-Closed ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702519235·Elvarex 3/Chap Style/Closed Toe, E-Version, Kne...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702407662·Elvarex 2/Knee High/Slant-Open Toe/Dotted 5 cm ...
Immunalysis
FDA UDI
IMMUNALYSIS CORP·00840937105160·Opiates Antibody Analyte Specific Reagent (ASR)
TRAM 2001 MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·September 8, 2015
SYRINGE 50ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 10, 2024
CPS SHORT ANCHOR PLUG 10MM
FDA Adverse Event
Injury
·.·Product code JWH·May 13, 2019
CPS TRANSVERSE PIN 6PK 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 13, 2019
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 20, 2023
LOCKING RECONSTRUCTION PLATE AXSOS 14 HOLE / L222MM 5.0MM LOCKING SET
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HRS·April 22, 2013
ANGIOSEAL
FDA Adverse Event
ST. JUDE MEDICAL, INC·Product code MGB·April 25, 2011
GE OEC 2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008
LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·September 9, 2015
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024