22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPLUS
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866650·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
FDA 510(k)
FDA Class 2
·Cardiovascular
BODY BOX 5500
FDA 510(k)
FDA Class 2
·Anesthesiology
SIEMENS 1.5T TXRX 15 CH KNEE
FDA Adverse Event
Other
·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011
RED DCI-DC3 SENSOR
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 15, 2015
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·March 23, 2022
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·July 14, 2022
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·February 17, 2017
CADD
FDA Adverse Event
Malfunction
·NULL·Product code FPA·August 17, 2021
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 6, 2011
INSIGNIA AVT
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·June 6, 2022
PKG, NEEDLE NOSE FORCEPS, P/N 0250080288. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021