21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intuitive Surgical EndoWrist Vessel Sealer Extend
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MULTIPLE NAME
FDA 510(k)
FDA Class 1
·General Hospital
MECTACER BIOLOX FORTE-FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017
VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·June 22, 2018
AMISTEM H, HA COATED STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2017
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 9, 2021
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2024
LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2019
DC EXTENSION CABLE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 10, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011
3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/20MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·June 17, 2013
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 29, 2023
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·October 16, 2020
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
QUADRA S FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 6, 2025
VERSAFITCUP DM ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015
STEM: AMISTEM H HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 5, 2022
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·January 11, 2023
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020