18 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508864·
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124603·Modular Offset Stem 17mm x 125mm 4mm
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TECO ISE REAGENT SET FOR CX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code DTB·June 7, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
HARMONIC SCALPEL GENERATOR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008
COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 25, 2017
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 26, 2019
NEEDLE 25X1-1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 5, 2019
IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code JWH·February 24, 2016
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022