20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502559·Gutta Percha Points is used to root canal filin...
NA
FDA UDI
aap Implantate AG·04042409097270·K-wire with thread and trocar point, ø2.5, L 270
HOVEROUND TEKNIQUE, MODEL HD-6
FDA 510(k)
FDA Class 2
·Physical Medicine
KSEA SIALOENDOSCOPES AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9611993-2024-102527
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·August 28, 2024
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·Product code FOZ·June 25, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 9, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 19, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·May 20, 2011
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
FDA Recall
Terminated
·Integra Life Sciences Corporation·Product code CAZ·July 13, 2009
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015