19 results
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19ms
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Sources: EU EUDAMED, US FDA
HYPERION X5
FDA 510(k)
FDA Class 2
·Radiology
Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow Meter
FDA UDI
A-M SYSTEMS, LLC·00817081023459·Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow...
Clinician's Choice® High Viscosity Tubes & Plugs
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002240·Dental material injection cannula, single-use
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122254·KWire .062x4" (1.6x100mm)
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702448252·ELVAREX 2/THIGH HIGH/SLANT-CLOSED TOE-ELEPHANTI...
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 13, 2026
HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
PINN CAN BONE SCREW 6.5MMX50MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·July 11, 2011
Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·September 19, 2018
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·March 8, 2021
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE
FDA Adverse Event
Injury
·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019
AIA-900
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code KHO·December 14, 2023
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·October 14, 2019
XP-CR Tibial Tray - Interlok 67mm Item # 195271
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019