20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORIGINS LIPOHARVESTING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517577238·CoRoent Ant TLIF PEEK, 12x10x32mm 8°
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664012939·SOSOFT 30-40 MM HG KNEE HIGH RIB MEDIUM WHITE 1...
Breast BI 7 Frame UI Set
FDA UDI
Noras MRI products GmbH·04251269206054·The intended use of Breast BI 7 MR Coil 1.5T / ...
N/A
FDA UDI
Tyber Medical, LLC·M695M1203280·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192863·
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101830·LDWR,SET,DIN,SNAP,5-LEAD,61CM/24IN,IEC,1/ST
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101823·LDWR,SET,DIN,SNAP,5-LEAD,102CM/40IN,IEC,1/ST
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 6, 2013
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
CLEARFIL MAJETY POSTERIOR
FDA 510(k)
FDA Class 2
·Dental
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 11, 2013
3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·May 20, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
OPTIFLOW JUNIOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·December 16, 2012
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024