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