48 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
FDA Recall
Open, Classified
·Echonous Inc·Product code IYN·May 9, 2024
IOLMaster 700
FDA Recall
Terminated
·Carl Zeiss Meditec AG Carl-Zeiss-Promenade 10 Jena Germany·Product code HJO·December 7, 2020
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
FDA Recall
Open, Classified
·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
FDA Recall
Open, Classified
·SEASPINE ORTHOPEDICS CORPORATION·Product code HWJ·June 4, 2024
Optimus Fixed Awl
FDA Recall
Terminated
·Amendia, Inc·Product code OVD·November 22, 2016
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
FDA Recall
Terminated
·Ebi, Llc·Product code OVE·November 11, 2014
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA, Inc·Product code OLO·July 12, 2023
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
FDA Recall
Terminated
·Abbott Spine·Product code NKB·July 18, 2007
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
FDA Recall
Terminated
·Abbott Spine·Product code NKB·July 18, 2007
PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.
FDA Recall
Terminated
·Abbott Spine·Product code NKB·April 17, 2008
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
FDA Recall
Open, Classified
·Product code OVD·July 15, 2024
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
FDA Recall
Open, Classified
·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code HWJ·July 7, 2023
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
EZ-DOP, diagnostic ultrasound imaging system
FDA Recall
Terminated
·DWL Systems, Inc.·Product code IYN·January 5, 2004
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014