18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sidestream
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730001401·SideStream Plus Filter Kit
MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
FDA 510(k)
FDA Class 2
·Dental
INTRALASE 600C LASER KERATOME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018
NEURON DELIVERY CATHETER 053
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·March 16, 2010
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019
TRIAGE D-DIMER TEST
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 4, 2025
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 29, 2013
PFC SIGMA A/P PLI TB 8MM,SZ 4
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 3, 2011
ACCURUS, TOTAL PLUS PAK
FDA Adverse Event
Malfunction
·ALCON LABORATORIES, INC.·Product code HQC·July 8, 2008
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