14 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
CLEANAIR/ CLEANWATER UNIT, MODEL 1600
FDA 510(k)
FDA Class 1
·Dental
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 3, 2023
TRI-LOCK BPS SZ 4 STD OFFSET
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 29, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 13, 2011
M SERIES
FDA Adverse Event
Death
·ZOLL MEDICAL CORP·Product code MKJ·July 25, 2008
Z NAIL CMF 5.0X70 ANT SUP SCR
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·October 15, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012