17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131255846·SENSEI, BTE 13 WL 90 RE
CaviWipes
FDA UDI
METREX RESEARCH, LLC·00615375005033·Disinfecting Towelettes Flatpack of PreSaturat...
Intramedullary Plugs
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575036905·Intramedullary Plug Impactor, threaded, L=400 m...
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
FDA 510(k)
FDA Class 2
·General Hospital
SMARTXIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962110621·SUTURE WIRE, 24 GAUGE
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·February 3, 2017
STAT PROFILE CRITICAL CARE XPRESS
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP.·Product code CHL·May 23, 2013
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·September 29, 2014
VITA 2 DDD
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·March 10, 2017
Single Shot Epidural Tray Catalog Number: 6183R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 20, 2017
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015