28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONICSTIMU COMBO THERAPEUTIC DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994239907·SCREW 3120217 4.0 X 17 SELF TAP FIX
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889289·SCREW 3120217 4.0 X 17 SELF TAP FIX
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007720·SOSOFT 15-20 MM HG KNEE HIGH RIB SMALL SAND 1 E...
Cortical Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120069816174·Cortical Screw, Cannulated, D=2.0mm, L=17mm
N/A
FDA UDI
Tyber Medical, LLC·M695M1202170·
SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·December 3, 2014
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197032872·Good tonsil scissor
190mm,...
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112800·LYNX Distal Tibial Antero Lat Locking Plate, Ti...
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
FDA 510(k)
FDA Class 2
·Cardiovascular
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ICON 25 HCG 8120217
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code JHI·June 26, 2009
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 8, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS, INC.·Product code DYB·June 6, 2011
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC·Product code DSQ·September 7, 2016
OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 10MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·March 15, 2024
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·June 29, 2016
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012