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Sources: EU EUDAMED, US FDA
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FDA UDI
COLLEGE PARK INDUSTRIES, INC.·00195411108411·Knee Pad Replacement Kit, Gray
NP STM TIB B/P LT SZ2 NAT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 16, 2023
AW 4.3 ADVANTAGE SIM
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS S.C.S.·Product code KPG·September 2, 2010
GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPG·November 24, 2010
LPG SYSTEMS
FDA registration
LPG SYSTEMS·4 products·🇫🇷 France
IPG MEDICAL CORPORATION
FDA registration
IPG MEDICAL CORPORATION·2 products·🇺🇸 United States
IPG MEDICAL CORPORATION
FDA registration
IPG MEDICAL CORPORATION·1 product·🇺🇸 United States
Detector UA 2
FDA UDI
Immunostics Company, Inc·10722355002245·Urine Reagent Strips (URS) for Urinalysis are f...
KSG MEDICARE SDN BHD
FDA registration
KSG MEDICARE SDN BHD·4 products·🇲🇾 Malaysia
DermLite DL5 Contact Plate - grid
FDA UDI
DermLite LLC·00850017651524·Removable glass contact plate with grid for DL5
APG Air-Plethysmograph
FDA UDI
ACI MEDICAL LLC·00860446000312·Pneumatic plethysmograph.
AIR PLETHYSMOGRAPH MODEL APG-1000
FDA 510(k)
FDA Class 2
·Cardiovascular
UltraScan CPG
FDA UDI
LUMENIS BE LTD·07290117771846·Direct Marking (DM): 07290117772089, 0729011777...
Calisto CPG
FDA UDI
IVOCLAR VIVADENT, INC.·D7076465460·Callisto CPG 31g
GLOBAL APG+
FDA UDI
DEPUY (IRELAND)·10603295102946·GLOBAL APG+ ANTI-ROTATION PEG INSERTER / REMOVER
GLOBAL APG+
FDA UDI
DEPUY (IRELAND)·10603295103059·GLOBAL APG+ LOW PROFILE PERIPHERAL REAMER SIZE 40
GLOBAL APG+
FDA UDI
DEPUY (IRELAND)·10603295105879·GLOBAL APG+ TRIAL SIZE 48
GLOBAL APG+
FDA UDI
DEPUY (IRELAND)·10603295104759·GLOBAL APG+ LOW PROFILE CENTRAL REAMER SIZE 40/...
GLOBAL APG+
FDA UDI
DEPUY (IRELAND)·10603295102984·GLOBAL APG+ STRAIGHT HANDLE OUTER
1100 CPG
FDA UDI
SIGVARIS INC·00745129265892·A tube-like garment made of elastic material(e....