22 results
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27ms
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Sources: EU EUDAMED, US FDA
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
FDA 510(k)
FDA Class 2
·Physical Medicine
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103150·Shaver, Closed, 15mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101150·Distractor, Smooth Paddle, Lordotic, 15mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101150·Distractor, Smooth Paddle, 15mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024106·Paddle Shaver, 15mm
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862004925·INSTRUMENT CASE, LOGIC™, SIZE 3.5
NA
FDA UDI
STRYKER CORPORATION·04546540346384·3.5mm Round Fluted Soft Touch
NA
FDA UDI
STRYKER CORPORATION·07613153000112·4.0mm Swanson Pilot Point Bur Medium
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
FDA 510(k)
FDA Class 2
·Cardiovascular
PRO.DUCT CATHETER, MODEL CTH03
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIATHLON SYMMETRIC X3 PATELLA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·March 19, 2013
MP50 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 11, 2011
PALIND 19/36 SLOT SPRT W/VT
FDA Adverse Event
Other
·TYCO HEALTHCARE/KENDALL·Product code MPB·March 10, 2008
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·October 4, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·October 4, 2019
Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Product distributed by Hoana Medical, Inc., 828 Fort St. Mall, Suite 620, Honolulu, HI
FDA Recall
Terminated
·Hoana Medical·Product code KMI·November 7, 2007
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·October 4, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 4, 2019
AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024