152 results · 25ms · Sources: EU EUDAMED, US FDA

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EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

FDA Recall
Open, Classified ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code MOB·May 24, 2023

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

FDA Recall
Open, Classified ·Philips North America·Product code DSI·January 18, 2023

IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

FDA Recall
Open, Classified ·Philips North America, LLC·Product code MHX·June 25, 2020

BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·November 6, 2024

BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

FDA Recall
Terminated ·Dukal Corp.·Product code FPY·June 1, 2017

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code NDE·November 9, 2016

MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

FDA Recall
Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

FDA Recall
Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-203

FDA Recall
Terminated ·Boston Scientific Corporation·Product code GBM·March 17, 2003

PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ. Sutures are intended for general soft tissue approximation and/or ligation.

FDA Recall
Terminated ·Ethicon, Inc. US·Product code GAM·February 2, 2009

Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114

FDA Recall
Terminated ·Product code GAM·June 6, 2007

Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

FDA Recall
Terminated ·Apogee Medical, Inc·Product code GBM·July 17, 2008

Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

FDA Recall
Terminated ·Apogee Medical, Inc·Product code GBM·July 17, 2008

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

FDA Recall
Open, Classified ·SURGICAL SPECIALTIES·Product code GAM·March 26, 2024

MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13

FDA Recall
Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H

FDA Recall
Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FDA Recall
Terminated ·Riverpoint Medical, LLC·Product code GAM·August 3, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FDA Recall
Terminated ·Riverpoint Medical, LLC·Product code GAM·August 3, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FDA Recall
Terminated ·Riverpoint Medical, LLC·Product code GAM·August 3, 2020

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FDA Recall
Terminated ·Riverpoint Medical, LLC·Product code GAM·August 3, 2020