18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00170951·
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214667·Cassettes are designed to contain incised tissu...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001095·artVeneer life lower anteriors, UBIS, A3
AOS CAPTURED CORTICAL SCREW 5.0mm x 95mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665019292·
Elite Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001095·Elite Short Handle Inserter
Synergy Disc Instruments
FDA UDI
Synergy Spine Solutions Inc·M67091000010950·Pilot Cutter, Large, 5mm
PREMIUM PLUS CEEA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013
3D KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·February 16, 2011
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAS·February 22, 2008
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
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