20 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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ClearEndoclip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034006529·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 6.35 x 8.0mm
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856001763·CP TI STRAIGHT ROD 5.5DIA X 170MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694089081·1.6mm Driver Stem, Hex SPD, Short
10PW - Penn Power & Light
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012179·10PW - Penn Power & Light
MEDTRONIC QUICK-SET PARADIGM
FDA Adverse Event
Malfunction
·MEDTRONIC MINI MED·Product code FPA·October 21, 2009
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
FDA 510(k)
FDA Class 1
·General Hospital
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CELLO BALLOON GUIDE CATHETER
FDA Adverse Event
Malfunction
·FUJI SYSTEMS CORPORATION·Product code DQY·July 24, 2023
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 2, 2016
ON-Q PAINBUSTER SOAKER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·October 1, 2008
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·August 11, 2011
TI STERNAL LOCKING STAR PLATE-12 HOLES
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDQ·July 1, 2013
iCT SP Model # 728311, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·May 6, 2020
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021