19 results · 33ms · Sources: EU EUDAMED, US FDA

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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