22 results · 27ms · Sources: EU EUDAMED, US FDA

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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