22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
FDA 510(k)
FDA Class 2
·Neurology
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970423·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970393·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970416·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970409·
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MPACT FLAT PE HC LINER Ø36/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 5, 2018
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 7, 2003
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 21, 2020
LINER: MPACT FLAT PE HC LINER Ø40/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 17, 2023
LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 16, 2024
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·May 20, 2013
FLIXENE GRAFTS
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code DSY·September 24, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·May 4, 2011
STEM: AMISTEM C CEMENTED LAT STEM SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 25, 2022
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023