21 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEMO 4D
FDA 510(k)
FDA Class 2
·Cardiovascular
BI-METRIC XR-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650565·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555068·
The VitalCough®System
FDA UDI
HILL-ROM SERVICES PTE. LTD.·00887761997295·Respiratory Care
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486002558·MCK Patellofemoral Component
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239892·
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000384·FUKUSHIMA SUCTION TUBE
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804110·FUKUSHIMA SUCTION TUBE
Dental Matrix System Wedges
FDA UDI
Denovo Dental, Inc.·00810059291256·Dental Matrix System Wedges - Small
8.0MHZ MICROVASCULAR PROBE
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020878·
PLATEAU SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VARIOUS DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 8, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·March 1, 2019
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·November 20, 2013
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018