18 results
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20ms
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Sources: EU EUDAMED, US FDA
OSDX HIP BMD SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PEAK MEDICAL
FDA UDI
Peak Medical Distribution Inc.·G45333180824020·Hibbs Retractor, Small, 1 inch x 5 inch Blade, ...
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153978·Tesera X Cage, 40mm x 22mm x 16mm, Convex 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153916·Tesera X Cage, 40mm x 22mm x 10mm, Convex 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153930·Tesera X Cage, 40mm x 22mm x 12mm, Convex 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153992·Tesera X Cage, 40mm x 22mm x 18mm, Convex 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153954·Tesera X Cage, 40mm x 22mm x 14mm, Convex 12°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523153893·Tesera X Cage, 40mm x 22mm x 8mm, Convex 12°
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010
EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWB·April 29, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 11, 2014
HUMAPEN MEMOIR
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code FMF·July 25, 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
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