18 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDRIVES, IDRIVEC, IDRIVEF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Thermaloy
FDA UDI
Rmo, Inc.·00885797017246·THERMALOY(R) PERFORMED NATURAL ARCH MX .014
Matira
FDA UDI
Kalitec Direct LLC·B073K0730000·Plate Bender, Universal
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position
Halyard
FDA UDI
O&M HALYARD, INC.·20680651107309·HALYARD H100,STRWRP,-,30X30,300
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183630·Tk XL Cage Insertion Instrument Case Tray 1
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183647·Tk XL Cage Insertion Instrument Case Tray 2
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183623·Tk XL Cage Insertion Instrument Case
METHADONE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GRAMS SILK NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 30, 2025
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·July 27, 2020
SUTURELASSO, 45 DEGREE, CURVE LEFT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·July 15, 2024
MAXIMO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 23, 2013
PFC*SIGMA C/S NPOR FE LT SZ2.5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965·Product code JWH·September 9, 2014
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 21, 2011
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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018