20 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Astroglide Warming
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·00822383525808·Raw MaterialsTurning Product Description: 10" B...
BALLARD™
FDA UDI
SUNMED, LLC·10889483564295·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Doub...
Ballard* Closed Suction System for Adults
FDA UDI
Avanos Medical, Inc.·00609038945040·BALLARD* Closed Suction Catheter, Double Swivel...
BALLARD™
FDA UDI
SUNMED, LLC·10889483564301·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, T-Pi...
BALLARD™
FDA UDI
SUNMED, LLC·10889483623442·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, Doub...
BALLARD™
FDA UDI
SUNMED, LLC·10889483564578·BALLARD™ TURBO-CLEANING CLOSED SUCTION SYSTEM F...
Ballard* Closed Suction System for Adults
FDA UDI
Avanos Medical, Inc.·00609038993713·BALLARD* Closed Suction Catheter, Double Swivel...
Ballard* Closed Suction System for Adults
FDA UDI
Avanos Medical, Inc.·00609038983127·BALLARD* Closed Suction Catheter, Double Swivel...
EN SNARE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PlaniMax Orthodontic Software
FDA 510(k)
FDA Class 2
·Dental
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code GZB·November 3, 2014
NC SPRINTER RX
FDA Adverse Event
Injury
·MEDTRONIC TIJUANA·Product code LOX·July 11, 2013
LAPIPLASTY SYSTEM S4A
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·November 29, 2017
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Recall
Terminated
·Halyard Health, Inc·Product code BSY·July 29, 2015
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·April 25, 2018