9 results
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27ms
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Sources: EU EUDAMED, US FDA
MODIFIED IDEIA CHLAMYDIA TEST
FDA 510(k)
FDA Class 1
·Microbiology
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
LITETOUCH DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·May 2, 2014
ONE TOUCH PING GLUCOSE MANGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·October 5, 2010
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
RX PERMANENT PACING LEAD
FDA Adverse Event
Injury
·OSCOR INC.·Product code DTB·November 19, 2021
SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative.
FDA Recall
Terminated
·Patterson Dental Supply, Inc.·Product code EBF·October 15, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012