12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TIMESH TITANIUM MINI-SOFTPLATE/SCREW
FDA 510(k)
FDA Class 2
·Dental
VARIO-PORT
FDA UDI
Richard Wolf GmbH·04055207022481·REDUCTION ADAPTER for reduction from Ø 7mm, Ø ...
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LATERAL STRAIGHT STEM 15.0 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·March 28, 2012
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 22, 2013
CLEARLINK SYSTEM EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code FPA·December 14, 2010
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·July 9, 2014
SULOX-HD 32 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·April 23, 2019
SULOX, HEAD, M¸ 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·August 3, 2018
SULOX-HEAD 28 M 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·April 4, 2019
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·March 7, 2018