21 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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COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001613·artVeneer life upper anteriors, ITS, BL3
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65890016130·Krom-Alginate Plus DF Fast Set
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967188218·Battalion, LLIF Trial, 0°, 16 mm Wide, 13 mm X ...
KONG-C VBR, End Plate & Screw, 0° / 16 x 13 mm
FDA UDI
icotec AG·07640164849959·KONG-C VBR, End Plate & Screw, 0° / 16 x 13 mm
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376380674·LIF, BROACH, STRAIGHT, 16MM X 13MM
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376381060·LIF, BROACH, CC OFFSET, 16MM X 13MM
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
FDA 510(k)
FDA Class 2
·Neurology
IVC THREE BLASTOCYST MEDIUM, CAT # 2007
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376647029·BROACH, LIF NAV, STRAIGHT, 16MM X 13MM
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 2, 2024
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 14, 2018
DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·July 10, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 11, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 25, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 2008
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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