18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONASTENT BILIARY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925016491·PISTON WITH ARMSTRONG PLATINUM RIBBON LOOP .6 M...
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034307928·Cancellous Screw, Cannulated, D=4.0mm, L=60m
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046367·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 60mm, ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295272915·DELTA XTEND REVERSE SHOULDER SYSTEM Cementless ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295272908·DELTA XTEND REVERSE SHOULDER SYSTEM Cementless ...
MODIFICATION TO URETERAL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LDR SPINE SPINETUNE TL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMISTEM H HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 22, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2026
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 20, 2021
SOLETRA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code MHY·May 31, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 3, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 15, 2011
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The ¿LIF features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The ¿LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences
FDA Enforcement
Class II
·Ongoing·Spinal Elements·May 30, 2018
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013