9,371 results
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57ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dandy Clear Aligners
FDA UDI
Orthly, Inc.·00860006891206·
GLENOSPHERE ORIENTATION GUIDE
FDA Adverse Event
Malfunction
·1818910 DEPUY ORTHOPAEDICS, INC.1818910 DEPUY ORTH·Product code LXH·February 23, 2015
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
LUNA G3 APAP
FDA Adverse Event
Injury
·BMC MEDICAL CO., LTD·Product code BZD·February 2, 2026
GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
FDA Recall
Terminated
·Gyrus Medical, Inc.·Product code GEI·May 15, 2006
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 20, 2013
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
RENEW HANDPIECE.
FDA Adverse Event
Malfunction
·MICROLINE SURGICAL, INC.·Product code GEI·June 21, 2016
GENERIC - NAVISTAR THERMOCOOL TC
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code OAD·January 13, 2010
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
LIBERATOR 60
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code BYJ·March 3, 2023
PURELY YOURS
FDA Adverse Event
Malfunction
·AMEDA INC.·Product code HGX·June 12, 2015
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
FDA Enforcement
Class II
·Terminated·Afassco Inc·August 15, 2012
SPATZ3 ADJUSTABLE BALLOON SYSTEM
FDA Adverse Event
Malfunction
·SPATZ FGIA INC.·Product code LTI·June 13, 2023
SPATZ3 ADJUSTABLE BALLOON SYSTEM
FDA Adverse Event
Malfunction
·SPATZ FGIA INC.·Product code LTI·June 13, 2023
INFUSOMAT®
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·May 21, 2021
INFUSOMAT®
FDA Adverse Event
Malfunction
·B.BRAUN MELSUNGEN AG·Product code FRN·December 28, 2023
INFUSOMAT®
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 4, 2022
INTERSTIM
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL·Product code EZW·August 25, 2006