19 results · 20ms · Sources: EU EUDAMED, US FDA

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HORIZON SURGICAL LIGATING AND MARKING CLIP

FDA 510(k)
FDA Class 2 ·Cardiovascular

24 Fr Infant Flexi Tip: Pediatric Enema Tip

FDA UDI
Bracco Diagnostics Inc.·10815112021624·Infant Flexi Tip

24 Fr Infant Flexi Tip: Pediatric Enema Tip

FDA UDI
Bracco Diagnostics Inc.·10815112021013·Infant Flexi Tip

POWER CUT PREPARATION SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013030·POWER CUT PREPARATION SCISSORS CURVED DOUBLE-AC...

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756094337·SLING & SWATHE

ShurFit MALIF System

FDA UDI
PRECISION SPINE, INC.·00840019925242·Cup Curette 4mm 90˚ Up Pulling

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV

FDA 510(k)
FDA Class 2 ·Hematology

BREAST IMMOBILIZATION DEVICE MR-BY 160

FDA 510(k)
FDA Class 2 ·Radiology

IV SET AN120 W/O BP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·May 9, 2019

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

PREFYX PPS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·January 8, 2013

INTEGRATED APD SET W/CASSETTE3-PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010

ACTIVELIFE

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020

ACTIVELIFE

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020

ACTIVELIFE

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020

ACTIVELIFE

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·February 10, 2020

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021