29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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