2,336 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code OOE·July 11, 2024
UNK - CAGE/SPACERS: SYNCAGE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code OVE·February 6, 2020
UNKNOWN CAGE/SPACER
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNH·February 6, 2020
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024
Lead, Delta Amino Levulinic Acid
FDA classification
FDA Class 2
·Lead, Delta Amino Levulinic Acid
SafeGait Active Dynamic Mobility Trainer
FDA UDI
DIH TECHNOLOGY INC.·00860012112821·SafeGait Active S1000 system (Model SGAS1000) i...
SafeGait 360 Balance and Mobility Trainer
FDA UDI
DIH TECHNOLOGY INC.·00860012112814·SafeGait 360 system (Model SG360) is a body wei...
SafeGait Active 360 Dynamic Mobility Trainer
FDA UDI
DIH TECHNOLOGY INC.·00860012112838·SafeGait Active 360 system (Model SGA360) is de...
directCHECK Whole Blood Controls
FDA UDI
ACCRIVA DIAGNOSTICS HOLDINGS, INC.·10711234540046·Protective Sleeves
Odontit
FDA UDI
ODONTIT S.A.·D914DI20·Paralleling Pin (2 packg.)
Dandy Vision
FDA UDI
Alliedstar Medical Equipment Co., Ltd.·06973993440884·
Dandy Vision
FDA UDI
Alliedstar Medical Equipment Co., Ltd.·06973993442864·
Lvivo Seamless
FDA UDI
DIA IMAGING ANALYSIS LTD·07290019352020·
Dib UltraNav Transseptal Catheter System
FDA UDI
Dib UltraNav Medical LLC·00860013955946·
Lvivo Standalone UI
FDA UDI
DIA IMAGING ANALYSIS LTD·07290019352037·
Dib UltraNav Transseptal Catheter System
FDA UDI
Dib UltraNav Medical LLC·00860013955953·
Dib UltraNav Transseptal Catheter System
FDA UDI
Dib UltraNav Medical LLC·00860013955960·
Lvivo Software Application Platform
FDA UDI
DIA IMAGING ANALYSIS LTD·07290019352006·
Lvivo Mobile
FDA UDI
DIA IMAGING ANALYSIS LTD·07290019352013·
Dib UltraNav Transseptal Catheter System
FDA UDI
Dib UltraNav Medical LLC·00860013955977·