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Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code DXE·August 9, 2012

Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FED·November 5, 2013

Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FED·November 5, 2013

Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FED·November 5, 2013

CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %" (10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15" X 20" LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125" x 85" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL (1) DRAPE SHEET 42" X 57" SMS (1) EAR ULCER SYRINGE 2oz. UF (1) RECEIVING BLANKET 100% COTTON (1) SCALPEL #20 WITH HANDLE (1) DURAPREP SURGICAL SOLUTION 26ml UF (2) ABSORBENT TOWEL 15" X 20" L.F (2) LITE GLOVES UF (1) BOWL WITH LID PLASTIC 80oz. (1) TABLE COVER REINFORCED 44" x 78" LIF (1) UTILITY BOWL 32oz (2) PAD OBSTETRICAL X-LARGE ST. (1) WRAPPER 30" X 30" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT Y." X 12' UF (1) MUCUSTRAP 20cc 1 OFR (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) UMBILICAL CORD CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OHM·May 20, 2014

LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

FDA Recall
Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes

FDA Recall
Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)

FDA Recall
Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·December 30, 2009

SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 9, 2012

EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

FDA Recall
Terminated ·Edwards Lifesciences Research Medical Inc·Product code DWF·November 19, 2004

Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 23, 2014

Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.

FDA Recall
Terminated ·Ethicon, Inc. US·Product code DWF·April 27, 2006

Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences

FDA Recall
Terminated ·Edwards Lifesciences Research Medical, Inc.·Product code DWF·April 18, 2006

Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008

Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·October 7, 2010

Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·October 7, 2010

Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007