13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020513·Perfect Fit Adult Effort Belt Sensors, (1-Chest...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702537338·Elvarex 1/Thigh High/Profile-Slant-Closed Toe/D...
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
K.E.P. CONNECTOR AND CLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
YO Home Sperm Test
FDA UDI
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.·07290016650242·
M2A 38MM MODULAR HEAD+6MM NK NO SKRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 3, 2013
IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 2011
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWY·November 2, 2015
TOTAL KNEE REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016
PATIENT SPECIFIC TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022