19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRONOVA NONABSORBABLE SUTURE, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00146251·
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040044407·Silver Point Forceps
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001625·artVeneer life lower anteriors, UIM, BL3
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 26, 2026
NA
FDA UDI
aap Implantate AG·04042409048043·K-wire with trocar point, ø1.6, L 250
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971215·
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 30, 2026
LIFECARD CF COMPACT RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
SCANDINAVIAN IVF SCIENCES AB, G1.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
aap Implantate AG·04042409048050·K-wire with trocar point, ø1.6, L 250
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2022
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2010
PINN MAR +4 NEUT 32IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 13, 2013
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·February 25, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024