41 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
FDA 510(k)
FDA Class 2
·General Hospital
Ormco
FDA UDI
ORMCO CORPORATION·00889989027235·SS BROAD ARCH UP SML 0210X0250 PK/10
SofTouch™
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·30813150021020·5 PER POUCH, 20 POUCHES/BOX, 6 BOXES PER CASE =...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756000611·CERV-O-COLLAR
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471155875·T Nat D 016 Up
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046285·
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869638784·MOSS 100 Pedicle Screw Inserter, Star 20, 1/4" ...
Young Specialties
FDA UDI
Young Innovations, Inc.·00840326425411·NiTi Thermal Archwire, NAT .016 Upper Dimple 10EA
OPTIDOS
FDA 510(k)
FDA Class 2
·Radiology
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
FDA 510(k)
FDA Class 2
·Anesthesiology
STEP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GCJ·September 12, 2018
UNKNOWN IV CATHETER
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·January 13, 2016
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·May 8, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014
XIA ROD DIA. 6 X 480
FDA Adverse Event
Other
·STRYKER SPINE BORDEAUX·Product code KWQ·May 18, 2011
Right Heart Catheter Product Line: Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery
FDA Enforcement
Class I
·Terminated·Symbios Medical Products, LLC·June 12, 2013
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016