14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PRO TENS, MODEL WL-240 RX
FDA 510(k)
FDA Class 2
·Neurology
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113383·LOCATOR R-Tx Abutment for 5.0mm Camlog Connecti...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481123306·LOCATOR F-Tx Abutment For 5.0mm Camlog Connecti...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605685·MAQUET ALPHAMAXX 2.25" DELUXE GEL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450287958·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450270134·
MXR-2000 MOBILE X-RAY UNIT
FDA 510(k)
FDA Class 2
·Radiology
HARDYDISK, TETRACYCLINE 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
LCS COMP RPS INS LG+ 10MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code NJL·April 26, 2013
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576
FDA Recall
Terminated
·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014