63 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304006515·
AGXO
FDA UDI
Oticon A/S·05707131288561·H110V2, DESIGNRITE 10 WL STG AGXO
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104736·OVAL BURR, 5.5MM, S
TEMP IT
FDA 510(k)
FDA Class 2
·Dental
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
FDA 510(k)
FDA Class 2
·Cardiovascular
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
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 5, 2008
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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
ORTHOPEDIC SALVAGE SYSTEM AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 28, 2017
ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 28, 2017