18 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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BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123546·Multi-Unit Verification Cylinder w/ Unigrip Screw
Preat Implant Prosthetics
FDA UDI
Preat Corporation·00842092165270·Multi-Unit Verification Cylinder w/Unigrip Scre...
TruForm
FDA UDI
Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123553·Multi-Unit Verification Cylinder w/Unigrip Scre...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092135655·Multi-Unit Verification Cylinder w/Unigrip Scre...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092129142·Multi-Unit Verification Cylinder w/Unigrip Scre...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092129111·Multi-Unit Verification Cylinder w/Unigrip Scre...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092123560·Multi-Unit Verification Cylinder w/Unigrip Scre...
STRYKER NAVIGATION SYSTEM - ENT MODULE
FDA 510(k)
FDA Class 2
·Neurology
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
FDA 510(k)
FDA Class 1
·General Hospital
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 12, 2013
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION DIV.·Product code LGW·February 23, 2011
LIGASURE ATLAS HANDSWITCHING 20CM
FDA Adverse Event
Malfunction
·COVIDIEN LP (US SURGICAL)·Product code GEI·February 20, 2008
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024