44 results · 15ms · 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.

AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

FDA Recall
Open, Classified ·Stryker Spine·Product code OVE·August 23, 2024

AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

FDA Recall
Open, Classified ·Linet Americas·Product code HDD·March 6, 2020

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

FDA Recall
Open, Classified ·IsoTis OrthoBiologics, Inc.·Product code MQV·November 27, 2024

Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System.

FDA Recall
Open, Classified ·Canary Medical, Inc.·Product code QPP·May 2, 2025

PREGNANCY TEST 24CT

FDA Recall
Open, Classified ·GOLD STAR DISTRIBUTION INC·Product code LCX·December 26, 2025

Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

FDA Recall
Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

FDA Recall
Open, Classified ·Braxton Medical Corporation·Product code FOZ·September 4, 2020

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

FDA Recall
Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

FDA Recall
Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT

FDA Recall
Open, Classified ·GOLD STAR DISTRIBUTION INC·Product code KGX·December 26, 2025

Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.

FDA Recall
Open, Classified ·GOLD STAR DISTRIBUTION INC·Product code EFW·December 26, 2025

ViewPoint; system, imaging processing, radiological

FDA Recall
Open, Classified ·GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany·Product code LLZ·August 8, 2024

Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.

FDA Recall
Open, Classified ·Pivotal Health Solutions, Inc.·Product code ITH·April 29, 2024

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

FDA Recall
Open, Classified ·Abbott·Product code OAE·September 10, 2025

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013

FDA Recall
Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

FDA Recall
Open, Classified ·Abbott·Product code OAE·March 24, 2022

EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006

FDA Recall
Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021