17 results
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23ms
·
Sources: EU EUDAMED, US FDA
MPS ACACIA PAIN KIT
FDA 510(k)
FDA Class 2
·General Hospital
Implant Prosthetics
FDA UDI
Preat Corporation·00842092103159·CAMLOG® Screw-Line-compatible 4.3mm Straight Mu...
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023369·The ENDO CARRY-ON Procedure Kit contains all of...
Lumenis Pulse 120H
FDA UDI
LUMENIS LTD.·07290109145457·
TRISTAR
FDA Adverse Event
Injury
·GUIDANT·Product code MAF·April 28, 2000
TORQUE INSTRUMENT, MODEL 8500
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO CD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 19, 2025
HT X-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·August 14, 2015
POLYAXIAL DUEL CORE SCREW
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 1, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 21, 2008
BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 13, 2018
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 21, 2025
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024