16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106587·LESTER FIXATION FORCEPS 1X2 TEETH
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
FDA 510(k)
FDA Class 2
·Anesthesiology
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PREMICATH PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·May 20, 2015
PREMICATH PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·May 22, 2015
PREMICATH
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·April 20, 2015
PREMICATH
FDA Adverse Event
VYGON GMBH·Product code LJS·April 20, 2015
PREMICATH PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·June 3, 2015
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 9, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 5, 2011
ORTHOPEDIC SALVAGE SYSTEM MOD ARTHRO 0 DEG LCK COLLAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·June 12, 2024
23GA ILLUMINATED DIRECTIONAL LASER PROBE
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQB·March 19, 2020
25GA ILLUMINATED DIRECTIONAL LASER PROBE
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQB·March 19, 2020
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017