14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
FDA 510(k)
FDA Class 2
·Cardiovascular
Printed Lower ROC Pack for Herbst LR4 14mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015650·
ASNIS
FDA UDI
Stryker GmbH·04546540131980·Tray Insert
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010560·Fixed, 10 electrode, HIS, 2mm electrode spacing
Elite®Opti-MIM® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707069940·.022 LR SOLO TUBE -25T OPTI-MIM DB
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER - FREE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Malfunction
·CORDIS SANTA CLARA·Product code MGB·July 29, 2022
THERMOPHORE HEATING PAD
FDA Adverse Event
BATTLE CREEK EQUIPMENT·Product code IRT·June 18, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 8, 2013
RACER BILIARY PERIPHERAL STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code FGE·November 12, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 15, 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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019