26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBRA Fusion Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165192·Rigid Retr prgs sharp
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181934·Integra® Jarit® Finger Rake Retractor, 6-1/2", ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812125·Schamberg Comedone Extractor, Medium, with Crimp
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 9, 2022
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
FDA 510(k)
FDA Class 2
·Orthopedic
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
FDA 510(k)
FDA Class 2
·Radiology
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·June 18, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
PRIME CARE (R) TRANSCEND ADVANCED MATTRESS
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL LLC·Product code IKY·September 18, 2014
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
ACHIEVE MAPPING CATHETER - 15 MM
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRF·August 14, 2019
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023