50 results · 21ms · Sources: EU EUDAMED, US FDA

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CEBOTOME DRILL

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA

FDA 510(k)
FDA Class 2 ·Anesthesiology

XIENCE SKYPOINT¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code NIQ·March 26, 2024

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024

SM PLUS BTT/OVAL BALLOON DISSECTOR

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GCJ·May 2, 2014

LINOX SD 65/16

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·October 9, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023

HF-RESECTION ELECTRODE, LOOP

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023

SMR CEMENTLESS FINNED STEM

FDA Adverse Event
Injury ·LIMACORPORATE SPA·Product code HSD·September 13, 2019

RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

FDA Recall
Terminated ·KCI USA, Inc.·Product code IOQ·June 27, 2012

BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.

FDA Recall
Terminated ·KCI USA, Inc.·Product code FNL·September 17, 2012

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.

FDA Recall
Terminated ·KCI USA, Inc.·Product code OMP·November 4, 2009

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord M426884 used with VAC ATS Canadian Model M8259994.

FDA Recall
Terminated ·KCI USA, Inc.·Product code OMP·November 4, 2009

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.

FDA Recall
Terminated ·KCI USA, Inc.·Product code OMP·November 4, 2009

3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper

FDA Recall
Open, Classified ·KCI USA, INC.·Product code OMP·January 17, 2025

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.

FDA Recall
Terminated ·KCI USA, Inc.·Product code IOQ·November 4, 2009

Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift

FDA Recall
Terminated ·KCI USA, Inc.·Product code FSA·April 6, 2012