19 results
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33ms
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Sources: EU EUDAMED, US FDA
EMIT TOBRAMYCIN CONTROL
FDA 510(k)
FDA Class 2
·Cardiovascular
Preat
FDA UDI
Preat Corporation·00842092155714·Screw Extractor Kit Internal Hex 3i Certain 4.1...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809613·Toomey to Luer Lock Needle 60cc Toomey Syringe,...
ALIGNER PLIERS
FDA UDI
Ortho Arch Company Inc·D90980015112·ALIGNER PLIERS - HOLE PUNCH
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100491·KIT, RAPID DEPLOYMENT-EMS - ORG
ACUMED
FDA UDI
Acumed LLC·10806378040283·Acu-Loc® Dorsal T-Guide Std, Right
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
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
FDA 510(k)
FDA Class 2
·Cardiovascular
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
FDA 510(k)
FDA Class 2
·Ophthalmic
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·October 1, 2008
TI COLLAR FOR USS VARIABLE AXIS SCREWS
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
ORCHESTRA
FDA Adverse Event
Malfunction
·SORIN CRM·Product code MRM·August 10, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021