20 results · 23ms · Sources: EU EUDAMED, 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