20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
FDA 510(k)
FDA Class 1
·General Hospital
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E89611623120·Surg.scissors cvd.14cm JOSEPH
Sklar®
FDA UDI
SKLAR CORPORATION·10649111100864·SE METZ STAND NLSON CVD 12" TC
RECAP/MAGNUM ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·August 30, 2017
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150457·16F x 2.3cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147839·16F x 2.3cm MiniSPC Low Profile Suprapubic Cath...
THERATRODE
FDA 510(k)
FDA Class 2
·Neurology
AXIOM PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M2A-MAGNUM MODULAR HEAD SIZE 42MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·March 15, 2017
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 11, 2013
DURALOC CONST LINER 58/70X32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·July 7, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 8, 2008
M2A-MAGNUM MODULAR HEAD SIZE 42MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·March 15, 2017
TTAP SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 28, 2018
RECAP/MAGNUM ACETABULAR SHELL 48 X 42MM POROUS COATED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·March 15, 2017
RECAP/MAGNUM ACETABULAR SHELL 48 X42MM POR SHELL COCR PC DIA48/42MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 20, 2012
M2A MODULAR HEAD COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 29, 2019
M2A - ALTERNATE BEARING METAL LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 29, 2019
QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 23, 2020
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022