10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450478660·
ENDOSCOPIC PLICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROJET CRONO
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN HERNIA STAPLER
FDA Adverse Event
Injury
·COVIDIEN·Product code GCJ·February 13, 2026
TRIATHLON CR FEM COMP #4 R-CEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 29, 2013
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 24, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 13, 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