12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083011369·Fixed, 10 electrode, CS, 2-8-2mm electrode spacing
ERA 3.25MM IMP 0DEG MICRO HEAD 15X2MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108419·Designed for both transitional and long-term de...
Printed Upper ROC Pack for Herbst UR5
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015310·
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981140595·Tab Remover
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
ENDO CLIP* II MED/LRF 10MM PISTOL GRIP
FDA Adverse Event
Injury
·COVIDIEN·Product code FZP·June 23, 2014
ARCHITECT HBSAG QUALITATIVE II
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code KSJ·January 8, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 9, 2010
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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