22 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: United States
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APEX™
FDA UDI
B. BRAUN MEDICAL INC.·04046964539183·EVA Single-Chamber Final Containers 1000 mL
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317328250·
Velocity™ Expandable Interbody System
FDA UDI
Spine Wave, Inc.·10840642106886·Expandable Implant, 22(L) X 10(W) X 8-14(H), Bi...
Unity
FDA UDI
DIOMEDICAL CO.,LTD.·08800039821292·SIJ Standard Thread OD12.5xL30
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105960·3.5mm Locking Medial Distal Tibial Plate, 14 Ho...
AA-1 SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 9, 2022
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 14, 2013
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code ELC·April 29, 2020
22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code ELC·May 31, 2023
18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 14, 2017
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021