17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GALILEOS FAMILY
FDA 510(k)
FDA Class 2
·Radiology
Protective Cap
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381471·
Forestanit®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21230701·Forestanit wire round hard clinic coil 0,70 mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230000·Rod Holder, Curved, 5.5 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197041980·CERA-CUT® Iris Scissors
straig...
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215006051·
Logical G-Series Acetabular Shell
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053932·
Ideal Eyes
FDA UDI
STRYKER CORPORATION·07613327062335·Arthroscope, Autoclavable, J-Lock, 70 ¿ View Di...
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 28, 2021
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
FDA 510(k)
FDA Class 2
·Orthopedic
VENTO Cup
FDA UDI
AMPLITUDE SAS·03701089514002·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
WHEELCHAIR COMPONENTS
FDA Adverse Event
UNKNOWN·Product code KNN·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 14, 2011
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 8, 2016