28 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Astroglide Organix Liquid
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Drill Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111221689·Drill Guide and Template
DEBAKEY FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060074·DEBAKEY FORCEPS
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930157·BIT, HEX MALE 5/32" AO
NA
FDA UDI
G & H Wire Company, Inc.·10190886246597·DISTAL SEGMENT - 19mm MINISCOPE COMPONENT RIGHT
3D KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
RS-4M+MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
Widex
FDA UDI
Widex A/S·05706069883022·WIDEX MOMENT MRB2D (Honey blond ) Telecoil, RIC...
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·August 11, 2022
Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code KQT·July 25, 2011
PROLIEVE THERMODILITATION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·October 15, 2008
PERISTEEN BAG/RECTAL CATHETERS
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code KNT·August 10, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 1, 2013
TALENT THORACIC STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011
U0308 XENIUM 210G SYNTH HFDIALYZER
FDA Adverse Event
Injury
·NIPRO CORP·Product code KDI·December 2, 2008
TALENT THORACIC STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 8, 2023
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 29, 2016
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 8, 2010