11 results
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19ms
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Sources: EU EUDAMED, US FDA
COOPERSURGICAL TRIAL TRANSFER CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SHARGHP A.V. FISTULA NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
FDA 510(k)
FDA Class 2
·Orthopedic
PROFILE BIABUT 4.0 -Ø5.5
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026
RELIANT DISPOSABLE PENCIL
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·February 26, 2013
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011
PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION LETTERKENNY·Product code LIT·April 2, 2008
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
FDA Enforcement
Class II
·Terminated·Childrens Medical Ventures·June 25, 2014
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023
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