28 results · 21ms · Sources: EU EUDAMED, 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