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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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