69 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Susceptibility Test Powders, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·GEOPEN SUSCEPTIBILITY POWDER
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304006515·
AGXO
FDA UDI
Oticon A/S·05707131288561·H110V2, DESIGNRITE 10 WL STG AGXO
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780466970·Integra® Jarit® Kirby Lens Loop and Muscle Hook
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812446·Vu-Mar XL Speculum - Pederson, Medium, 10cm x 2...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306808470·Marina Sacral Colpopexy tip, Flat on both sides...
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477238·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250413200·ceraMotion® PZr Press Liner C4, 20 g / dental c...
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104736·OVAL BURR, 5.5MM, S
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102749·DISPOSABLE ARTHROSCOPIC 5.5mm OVAL BURR, COMPAT...
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 29, 2015
HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 3, 2015
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
CONMED MACROLYTE INFANT DISPER ELECT.
FDA Adverse Event
Other
·CONMED CORP.·Product code JOS·November 22, 1999
MINIMED INFUSION PUMP
FDA Adverse Event
Malfunction
·MINIMED INC.·Product code FRN·February 20, 1998
SYNTHES
FDA Adverse Event
Injury
·SYNTHES·Product code HRS·August 30, 2001
OSS POLY BUMPER LOCK PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·September 14, 2020
ONCOLOGY SALVAGE SYSTEM- OSS LOCKING PIN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 26, 2017
ONCOLOGY SALVAGE SYSTEM- OSS TIBIAL BUSHING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 26, 2017
ONCOLOGY SALVAGE SYSTEM- OSS FEMORAL BUSHINGS QTY. 2
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 26, 2017