29 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.

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.

FDA Recall
Open, Classified ·American Contract Systems Inc·Product code OJH·July 14, 2025

iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

FDA Recall
Open, Classified ·Medical Depot Inc.·Product code CAW·April 11, 2025

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·March 9, 2026

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·March 9, 2026

Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

FDA Recall
Open, Classified ·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code KRI·June 27, 2025

BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTR·May 18, 2023

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTN·May 18, 2023

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

Parvovirus B19 IgG EIA kit Part No. V519IGUS

FDA Recall
Open, Classified ·Diasorin Inc.·Product code MYL·July 17, 2020

QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

FDA Recall
Open, Classified ·Maquet Medical Systems USA·Product code DTQ·May 18, 2023

Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

FDA Recall
Open, Classified ·Western/Scott Fetzer Company·Product code CAN·January 3, 2023

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

FDA Recall
Open, Classified ·Western/Scott Fetzer Company·Product code CAN·October 16, 2021

Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603

FDA Recall
Open, Classified ·Western/Scott Fetzer Company·Product code CAN·October 16, 2021

Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

FDA Recall
Open, Classified ·Western/Scott Fetzer Company·Product code CAN·October 16, 2021