29 results · 23ms · Sources: EU EUDAMED, US FDA

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YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828114622·GEN4 INTERACTIVE

Zavation

FDA UDI
Zavation LLC·00842166196537·Whitney TLIF 25, 6deg 8mm

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383502474·Gutta Percha Points is used to root canal filin...

EQUIPMENT DRAPES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MU PHOTONICS PAIN THERAPIST

FDA 510(k)
FDA Class 2 ·Physical Medicine

NIAGARA® Lateral Access System

FDA UDI
VB Spine LLC·10888857518032·Anterior Blade (Wide Long)

LUX Expandable Interbody System

FDA UDI
XENIX MEDICAL LLC·00840493415970·Lumbar Expandable, 10x25x8-12mm, 8 Deg

LUX Expandable Interbody System

FDA UDI
XENIX MEDICAL LLC·00840493415963·Lumbar Expandable, 10x25x8-12mm, 0 Deg

Model

FDA UDI
BICON, LLC·00813110024657·5.0 x 6.0mm Large Plastic Implant Replica

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

FDA Adverse Event
Malfunction ·STOCKERT GMBH·Product code DRF·May 9, 2013

ACETABULAR REAMER SHAFT

FDA Adverse Event
Malfunction ·GREATBATCH MEDICAL SA·Product code EJB·August 27, 2014

SYSTEM 5 SAGITTAL SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 19, 2011

CORTRAK2 NG/NI FEEDING TUBE W/ELECTROMAG TRANSMITTING STYLET W/ ENFIT CONNECTOR

FDA Adverse Event
Malfunction ·AVANOS MEDICAL INC.·Product code KNT·August 30, 2021

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025