9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
FDA 510(k)
FDA Class 2
·Orthopedic
C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO
FDA 510(k)
FDA Class 2
·Dental
Agape Cooling Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·May 8, 2014
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code JAK·October 15, 2012
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·August 10, 2010
The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FCK·November 3, 2011
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·September 21, 2022
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021