23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EN BLOC BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114148·SIMCOE I/A SYSTEM 23GA (PK/3)
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159002904·Jacobson Micro Needle Holder Round Handle
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350031900·MP - Ti/B100 Rod
BD DISCARDIT II 10 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 13, 2020
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTART MRX - EMS DXEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
DORADO PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·February 22, 2008
BD DISCARDIT II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 11, 2020
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·March 7, 2022
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code KKX·October 8, 2014
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024