14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm
#2- Round Knife, 2mm, Angled Tip
FDA UDI
KATALYST SURGICAL LLC·00840096203912·#2- Round Knife, 2mm, Angled Tip
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 80mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025330·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609409·ALLEN, STERIS-AMSCO 3.25" SOFTCARE PLUS
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 19, 2022
SPINE SYSTEM EVOLUTION
FDA 510(k)
FDA Class 2
·Orthopedic
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
FDA Enforcement
Class III
·Terminated·Advanced Sterilization Products·December 11, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 26, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 21, 2008
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011
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