22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
FDA 510(k)
FDA Class 2
·Cardiovascular
AngioDynamics
FDA UDI
ANGIODYNAMICS, INC.·H7877001026480·Thermo Pad Adapter Cable
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383557184·Gutta Percha Points is used to root canal filin...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383534284·Gutta Percha Points is used to root canal filin...
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
HI-TORQUE WINN GUIDE WIRE FAMILY
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTUNE RP TIB BASE SZ 5 CEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·March 18, 2024
THERMOPAD
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC.·Product code GEI·May 30, 2013
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013
59T EZ GLIDE STAIR CHAIR
FDA Adverse Event
Injury
·FERNO-WASHINGTON, INC.·Product code FPO·September 10, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 26, 2018
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
FDA Recall
Terminated
·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DYB·September 23, 2013
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
FDA Enforcement
Class I
·Terminated·Baylis Medical Corp *·November 13, 2013
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
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
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021
ACCOLADE DR SL (Model L301)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025