18 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VOCO PROFLUORID L
FDA 510(k)
FDA Class 2
·Dental
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008839·3.0mm x 36mm Lag Screw
Non-Locking Screw, 2.7mm x 36mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026405·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035323·3.0 x 36mm Lag Screw, Sterile
Havasu
FDA UDI
STRYKER CORPORATION·07613327541540·IV Pole
OsteoMed
FDA UDI
OSTEOMED LLC·00845694067683·3.0 x 36mm Lag Screw Sterile Qty 5
NOMOS MOTORIZED CRANE II
FDA 510(k)
FDA Class 2
·Radiology
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
FDA 510(k)
FDA Class 1
·Ophthalmic
EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2019
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 29, 2013
ENTERRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LNQ·May 5, 2011
ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 23, 2008
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·August 13, 2021
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 27, 2022
COONS DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 28, 2022
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