18 results
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28ms
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Sources: EU EUDAMED, US FDA
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,
FDA 510(k)
FDA Class 2
·Cardiovascular
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120214551·Carbide - Finishing burs
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 45cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665022186·
ACCUWELL TSH, MODEL KAW-TSH-960
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 26, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 16, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·March 24, 2008
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Death
·ETHICON INC.·Product code FTL·February 18, 2022
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 8, 2021
NEEDLE 30X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 29, 2021
BD PRECISIONGLIDE¿ NEEDLES
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 13, 2023
BD PRECISIONGLIDE¿ NEEDLES
FDA Adverse Event
Injury
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 31, 2023
NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 18, 2019
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 31, 2019
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015