20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
FDA 510(k)
FDA Class 2
·Anesthesiology
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type
MX8000 IDT CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
PASS LP
FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 29, 2013
ENDOPATH** ETS45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011
IN TOUCH ZX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC, LP·Product code FNL·July 21, 2008
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·March 29, 2017
ONYX
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code MFE·March 29, 2017
TRUFILL DCS ORBIT T DETACHABLE COIL SYSTEM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code HCG·July 6, 2017
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·May 8, 2009
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
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