14 results · 25ms · Sources: EU EUDAMED, 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