24 results
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23ms
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Sources: EU EUDAMED, US FDA
SURGITEK FOERSTER MAMMARY BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100743·KIT, CCR-MEDIC LEG RIG - MTC; This kit contains...
ACUMED
FDA UDI
Acumed LLC·10806378040658·2.0mm Locking Drill Guide 4mm-32mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197491372·Malleable Retractor Blade, with lip
51x168...
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
FDA 510(k)
FDA Class 2
·Dental
2.0MM LOCKING DRILL GUIDE 4MM-32MM
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·September 26, 2024
SMR GLENOID PEG TT SMALL-R #L
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·February 24, 2020
2.0MM LOCKING DRILL GUIDE 4MM-32MM
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·July 18, 2024
2.0MM LOCKING DRILL GUIDE 4MM-32MM
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·November 18, 2024
BIVONA CUSTOM TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL MD, INC.·Product code JOH·April 30, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 8, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
2.0MM LOCKING DRILL GUIDE 4MM-32MM
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·January 16, 2025
ACU-LOC® 2 VDR PROXIMAL T-GUIDE NARROW R
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code HWC·December 15, 2023
BIOLOX DELTA HEAD M Ø36MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code LZO·November 21, 2018
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·October 12, 2020
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 5, 2024
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022