16 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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THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
FDA 510(k)
FDA Class 2
·General Hospital
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740918550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674091855060·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450316078·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587C09185540·9mm H x 18mm W x 55mm L x 4 degree XLIF Coronal...
MICASEPT CIRADUR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920918550050·MICASEPT CIRADUR NEEDLE HOLDER STRAIGHT WITH HE...
MICASEPT CIRADUR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920918550250·MICASEPT CIRADUR NEEDLE HOLDER STRAIGHT WITH FO...
MICASEPT CIRADUR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896007987·MICASEPT CIRADUR NEEDLE HOLDER STRAIGHT WITH HE...
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 31, 2023
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
WAMPOLE HS-CRP ELISA
FDA 510(k)
FDA Class 2
·Immunology
PASSPORT V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 28, 2014
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·May 17, 2011
ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code GEI·January 3, 2020
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