50 results · 17ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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

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

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

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

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

Optimus Fixed Awl

FDA Recall
Terminated ·Amendia, Inc·Product code OVD·November 22, 2016

Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

FDA Recall
Terminated ·Biomet Spine, LLC·Product code OVD·August 22, 2013

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

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

Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

FDA Recall
Terminated ·Biomet Spine, LLC·Product code OVD·August 22, 2013

PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

FDA Recall
Terminated ·Valorem Surgical LLC·Product code MNI·June 21, 2017

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

FDA Recall
Open, Classified ·LSL Healthcare Inc.·Product code OXQ·March 9, 2026

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

FDA Recall
Open, Classified ·LSL Healthcare Inc.·Product code OXQ·March 9, 2026

EZ-DOP, diagnostic ultrasound imaging system

FDA Recall
Terminated ·DWL Systems, Inc.·Product code IYN·January 5, 2004

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

FDA Recall
Open, Classified ·LSL Healthcare Inc.·Product code OXQ·March 9, 2026

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

FDA Recall
Open, Classified ·LSL Healthcare Inc.·Product code OIB·March 9, 2026

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

FDA Recall
Open, Classified ·LSL Healthcare Inc.·Product code OVN·March 9, 2026

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

FDA Recall
Open, Classified ·LSL Healthcare Inc.·Product code OWL·December 22, 2025