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

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CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDLINE ASEP PLUS SURGICAL DRAPES

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

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G

FDA 510(k)
FDA Class 2 ·Immunology

X3 TRIATHLON CS INSERT #3 9MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014

ELECSYS HCG + BETA TEST SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·January 26, 2022

HEARTSTART XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013

JOSTENT GRAFTMASTER

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 19, 2008

SILK SUTURE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAP·April 19, 2011

ARCHITECT IPTH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code CEW·March 19, 2025

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015