181 results
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Sources: EU EUDAMED, US FDA
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Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KDC·June 22, 2004
Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009
Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator, Sterion Inc., Ham Lake, MN; REF 332263. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009
Radionics Disposable Grounding Plate
FDA Recall
Terminated
·Valleylab, Inc·Product code HAM·July 16, 2003
Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
FDA Recall
Terminated
·Valleylab, Inc·Product code HAM·July 16, 2003
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
FDA Recall
Terminated
·ConMed Corporation·Product code HAM·December 27, 2012
Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
FDA Recall
Terminated
·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JIX·June 5, 2018
GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC
FDA Recall
Terminated
·General Electric Med Systems·Product code EAM·March 30, 2004
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FAM·April 6, 2016
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations
FDA Recall
Terminated
·Pentax Medical Company·Product code FAM·April 6, 2016
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B
FDA Recall
Open, Classified
·Intuitive Surgical, Inc.·Product code NAY·October 7, 2022
BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
FDA Recall
Terminated
·Stryker Communications·Product code BRY·March 17, 2014
BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
FDA Recall
Terminated
·Stryker Communications·Product code BRY·March 17, 2014
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing LLC·Product code DZE·October 7, 2019
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.
FDA Recall
Terminated
·Tec Com Gmbh Eingang B Am Krummling 1 Kabelsketal Germany·Product code DWJ·August 14, 2018