45 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
FDA Enforcement
Class II
·Terminated·Synvasive Technology Inc·April 24, 2013
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·July 5, 2017
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16C
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE SCOPE Procedure tray Catalog Number: COKN48L
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024