14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASY ROD
FDA 510(k)
FDA Class 2
·Orthopedic
LIFT CHAIR, MODEL C5
FDA 510(k)
FDA Class 2
·Physical Medicine
Well-Root ST
FDA 510(k)
FDA Class 2
·Dental
HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS
FDA Adverse Event
Malfunction
·EES-SMITHFIELD·Product code KNF·February 20, 1997
ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·February 20, 1997
ONCOLOGY SALVAGE SYSTEM- OSS CEMENTED IM STEM 9MMX90MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 28, 2017
ONCOLOGY SALVAGE SYSTEM- OSS CEMENTED IM STEM 12X150
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 27, 2017
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 15, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·January 6, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 31, 2014
ONCOLOGY SALVAGE SYSTEM- CEMENTED IM STEM 9MMX90MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017
Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise Listing number: D072377 Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.
FDA Recall
Terminated
·Teco Diagnostics·Product code KQO·October 14, 2011
Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
FDA Recall
Terminated
·Teco Diagnostics·Product code KQO·October 14, 2011
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020