12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEONE SPA
FDA UDI
LEONE SPA·08033707018018·CALIBRA 1ST MOLAR BANDS n.LL 14
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695588·Dynamic Dental Implant Ø5mm L11.5mm
Hip Fastener Coupler
FDA UDI
Osteocentric Technologies, Inc.·00816950029455·Hip Fastener Coupler
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
FDA 510(k)
FDA Class 2
·Cardiovascular
STA- COAG CONTROL (N+ABN) PLUS
FDA 510(k)
FDA Class 2
·Hematology
AUTO DETECT FOR TELAHEART DR200/E-A
FDA 510(k)
FDA Class 2
·Cardiovascular
AMISTEM H HA COATED STD STEM SIZE3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 11, 2018
UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JLW·August 19, 2011
CROSS-LINK-CLAMP F/R Ø6 PREASSMBL TAN DB
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·June 14, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 20, 2011
PEG SMOOTH 2.0X18MM
FDA Adverse Event
Injury
·DEPUY ACE S.A. 'R.L.·Product code LXT·September 18, 2008
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024