44 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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