22 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Premier Carvers
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009323·Carver DE_Acorn 21C
Imola-Silverstone
FDA UDI
Altus Spine, LLC·00843210133409·Main Blade, 90mm Long
CorticaLINK
FDA UDI
LINKSPINE, INC.·00817329022398·Ti Rod - Straight - 90mm
Nex-Link OCT®
FDA UDI
ZIMMER SPINE, INC.·00889024337886·
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116498·
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116511·
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116481·
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116504·
PROVIDER PUMP SET
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code FPA·August 15, 1994
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·May 18, 2011
2520274-2013-01445
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MNI·March 13, 2013
ROD TO ROD COUPLING HOFFMAN II COMPACT 5/5MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code JEC·February 8, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·June 23, 2021
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
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