22 results · 22ms · Sources: EU EUDAMED, US FDA

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CLEAN AND BOOST

FDA 510(k)
FDA Class 2 ·Dental

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

Unity Total Knee System

FDA UDI
CORIN LTD·05056139243912·UNITY KNEE™ PS-C INSERT - Size 6 x 20mm

Bard® Urethral Catheter

FDA UDI
C. R. Bard, Inc.·00801741029998·Bard® Tiemann Model Urethral Catheter Coude Tip

APEX PS Knee

FDA UDI
Omni Life Science, Inc.·00841690113416·PS Insert, Size 6 x 20mm

M-Flex®

FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020005·Blue Silicone Tungsten Maloney Esophageal Dilat...

PMT® CORPORATION HALO

FDA UDI
PMT CORPORATION·10650551093043·HEADBLOCKS, FOR USE WITH OPEN BACK HALO RINGS

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383556545·Gutta Percha Points is used to root canal filin...

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101017·Poly Insert UCCS, Size 6, 20mm

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550

FDA 510(k)
FDA Class 2 ·Cardiovascular

BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)

FDA 510(k)
FDA Class 2 ·Orthopedic

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·November 29, 2012

AMPLATZER TORQVUE DELIVERY SYSTEM

FDA Adverse Event
Injury ·AGA MEDICAL CORPORATION·Product code DQY·July 3, 2012

ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 24, 2013

ADULT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 28, 2012

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·July 28, 2014

BRYAN CERVICAL DISC SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 10, 2011

MICRUSFRAME18 7MM X 14.3CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022

MICRUSFRAME10 7MM X 30CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022