22 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REMSTAR PRO WITH C-FLEX CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310218613·FG Diamond 909-039 wheel regular 5/pack
PORTUX CAD/CAM Disc. 98.5X 20mm A2. ML
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126710011·PORTUX CAD/CAM Disc. 98.5X 20mm A2. ML
COR-SUTURE® QUICK LOAD®
FDA UDI
LSI Solutions, Inc.·00850200006346·COR-SUTURE® QUICK LOAD® SURGICAL SUTURE, 2-0 PO...
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LANTERN DELIVERY MICROCATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·November 25, 2019
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 2, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 26, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2011
LINOX SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code LWS·March 28, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 31, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·October 14, 2021
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2014
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014