558 results
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44ms
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Sources: EU EUDAMED, US FDA
G Surgical LLC
FDA registration
G Surgical LLC·10 products·🇺🇸 United States
GPS Anterior Cervical Plate System
FDA UDI
G SURGICAL LLC·M999CSS040120·4.0 mm x12 mm Length, Cortical
GPS Anterior Cervical Plate System
FDA UDI
G SURGICAL LLC·M999CTL418930·T LOK CERVICAL PLATE 4 LEVEL 18 MM X 93 MM
GPS Anterior Cervical Plate System
FDA UDI
G SURGICAL LLC·M999CSS018030·Locking Screw 1.8 mm x 3 mm
POWERLED
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·October 5, 2018
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 29, 2024
NEXUS® STANDARD HANDPIECE
FDA Adverse Event
Injury
·MISONIX, INC.·Product code LFL·July 18, 2023
NEXUS® STANDARD HANDPIECE
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·May 10, 2023
MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·January 23, 2024
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·February 5, 2020
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 2, 2024
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·October 2, 2024
VOLISTA STANDOP
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·June 12, 2019
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Recall
Terminated
·ROi CPS LLC·Product code LRO·January 3, 2020
Acuña Fombona, S.A.
Importer
🇪🇸 Spain·7 Manufacturers
European Healthcare & Device Solutions Ltd.
Authorized representative
🇮🇪 Ireland·66 Manufacturers·867 Devices
Stryker EMEA Supply Chain Services BV
Importer
🇳🇱 Netherlands·48 Manufacturers
Trilliant Surgical, LLC
Manufacturer
🇺🇸 United States
Key Surgical LLC
Manufacturer
🇺🇸 United States
Aurora Surgical LLC
Manufacturer
🇺🇸 United States