27 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EBI XFIX DFS RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TruLock
FDA UDI
Rmo, Inc.·00885797644947·TRULOCK Primer Activated Adhesive Mini Kit (1ea...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014601762·Toboggan Arm & Leg Guards, Medium
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873979129·15AACAAAAAAAAAAAAAAAAAAALP15 MONITOR/DEFIB
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
FDA 510(k)
FDA Class 2
·Cardiovascular
TORNIER TOTAL ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Quantum
FDA UDI
SPECTRUM MEDICAL LIMITED·05060434422088·Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD...
Sterile LeadConfirm
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290114064002·
NeuroSmart / NeuroNav LeadConfirm P Cable
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290114063944·
Sterile LeadConfirm
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290114064460·
LOCK SELF-CENTERING HEAD Ø47
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·September 19, 2022
CEMENTED GLENOID 3 PEGS SMALL
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code KWS·June 16, 2023
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·May 2, 2025
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·March 8, 2007
ASR UNI FEMORAL IMPL SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 12, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 18, 2011
PFC MOD DOME PATELLA 38MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code JWH·February 18, 2008
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018