94 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Brisbane ALIF Device, Gladstone ALIF Device
FDA 510(k)
FDA Class 2
·Orthopedic
External Fixation
FDA UDI
Life Spine, Inc.·00190837023010·Washer
SANTORINI Corpectomy Cage System
FDA UDI
VB Spine LLC·10888857243149·Bone Packing Mold Size 12x17 mm
AKITA2 APIXNEB
FDA 510(k)
FDA Class 2
·Anesthesiology
RESTORATION ACETABULAR WEDGE AUGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 21, 2020
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 21, 2020
NI
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 4, 2021
M2A MAGNUM PF CUP 52MM O.D. X 46MM I.D.
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 30, 2022
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 30, 2022
BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 31, 2023
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 2, 2020
UNK LINX MAGNETIC IMPLANT
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·September 13, 2019
Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.
FDA Enforcement
Class II
·Terminated·Sysmex America, Inc.·September 5, 2018
Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019