3,400 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEW IMAGE DRAINABLE TOUCH W/LOCK'N ROLL
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·September 3, 2010
NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING
FDA Adverse Event
Injury
·HOLLISTER INCROPORATED·Product code EXB·November 19, 2019
NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·November 5, 2019
NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1" PS
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·July 2, 2019
NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·October 29, 2019
NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·October 29, 2019
NEW IMAGE TWO-PIECE POUCHING SYSTEM
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·December 3, 2019
NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT
FDA Adverse Event
Injury
·HOLLISTER INCORPORATED·Product code EXB·November 26, 2019
Go Bed II+ Model FL 28 Ex 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
Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.) Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark. These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code EXB·July 27, 2011
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
FDA Recall
Terminated
·Convatec Inc.·Product code EXB·June 22, 2011
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.
FDA Recall
Terminated
·Convatec Inc.·Product code EXB·February 1, 2011
Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558
FDA Recall
Terminated
·ConvaTec·Product code EXB·February 14, 2008
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
FDA Recall
Terminated
·ConvaTec·Product code EXB·March 7, 2008
Collector, Ostomy
FDA classification
FDA Class 1
·Collector, Ostomy
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
Vasoview 7XB
FDA UDI
MAQUET CARDIOVASCULAR LLC·00607567700369·Vasoview 7XB
Syrebo
FDA UDI
Shanghai SiYi Intelligent Technology Co., Ltd.·06973408900019·The product is suitable for patients with certa...
Exo-s Saint-Damien Inc.
FDA registration
Exo-s Saint-Damien Inc.·1 product·🇨🇦 Canada
NCB, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 31, 2018