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ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

FDA Recall
Completed ·Materialise USA LLC·Product code HWT·July 13, 2022

Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.

FDA Recall
Terminated ·Phillips Nuclear Medicine·Product code INQ·January 26, 2009

ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.

FDA Recall
Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. UI. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI Poland·Product code INQ·June 29, 2016

Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).

FDA Recall
Terminated ·Integra LifeSciences Corp.·Product code OYK·November 17, 2011

IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

FDA Recall
Terminated ·Data Innovations, LLC·Product code JQP·August 29, 2018

3 in 1 STI Test

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code OUY·November 3, 2025

PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.

FDA Recall
Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

8 in 1 STI Test Kit

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code OUY·November 3, 2025

2 in 1 Trichomonas / Gardnerella Test

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code OUY·November 3, 2025

Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)

FDA Recall
Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

FDA Recall
Open, Classified ·Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China·Product code LJX·November 22, 2025

Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).

FDA Recall
Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

FDA Recall
Terminated ·Aesculap, Inc.·Product code LXH·May 9, 2012

ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025

ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025

ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025

THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.

FDA Recall
Terminated ·Lansinoh Laboratories Inc·Product code IME·August 14, 2012

PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

FDA Recall
Terminated ·Teleflex Medical·Product code GCD·April 21, 2017

Biomet Vanguard microplasty slidex femoral 4-in-1 block, 62.5 mm, stainless steel; Ref. 32-485103.

FDA Recall
Terminated ·Biomet, Inc.·Product code HTZ·May 16, 2005

Biomet Vanguard microplasty slidex femoral 4-in-1 block, 80 mm, stainless steel; Ref. 32-485108.

FDA Recall
Terminated ·Biomet, Inc.·Product code HTZ·May 16, 2005