17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm
BILOX PROSTHESIS HEAD 12/14 28MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES ANKLE ARTHRODESIS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
BIOLOX PROSTHESIS HEAD 12/14 32MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
2.4MM TI VA-LCP DRSL DSTL RAD L-PLATE +90°/2H HD/3H SHAFT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·April 29, 2013
3.5MM LOCKING SCREW SELF-TAPPING 45MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·April 29, 2011
INVACARE LITS AND SLINGS
FDA Adverse Event
Injury
·INVACARE CORP - MFG FACILITY·Product code FNG·July 9, 2008
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021