28 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
DEPUY SPINE, LLC·10705034007014·SPINAL INSTRUMENT TRIAL INSERTER WASHER 13mm
TruFlex™
FDA UDI
Ortho Organizers, Inc.·00190707125301·TRUFLEX NiTi Euro Upper 20x20 (10pk)
TruFlex
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730013309·NiTi Euro Upper 20x20 10 archwires per pack
PRCT2
FDA UDI
FX SOLUTIONS·03701037303207·PRCT2, PRCT II PLATE TA6V LEFT 13 HOLES
PRCT2
FDA UDI
FX SOLUTIONS·03701037310939·PRCT II PLATE TA6V LEFT 13 HOLES
e-vive NMES System; Small/Medium, Right
FDA UDI
Motive Health, Inc.·00854816006875·e-vive NMES System; Small/Medium, Right
Midmark IQholter EX Digital Holter
FDA UDI
MIDMARK CORPORATION·00841709100604·The Midmark IQholter EX system combines a compa...
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
FDA 510(k)
FDA Class 2
·Cardiovascular
AVL OPTI R ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RSP SHOULDER
FDA Adverse Event
ENCORE MEDICAL, L.P.·Product code KWS·March 12, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 18, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·February 19, 2008
EQUINOXE RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 7, 2023
STERILE 3.5 SOFT KOH-EFF
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HEW·November 28, 2018
H-MAX S LATERALIZED FEMORAL STEM #14
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MEH·December 17, 2021
STERILE 3.0 SOFT KOH-EFF
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HEW·February 20, 2019
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
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·July 10, 2024
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013