10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Keystone HB VPS
FDA UDI
Keystone Industries·H66860817071·HB VPS Heavy Body Fast Set
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
FDA 510(k)
FDA Class 2
·Physical Medicine
COBAS B 221<6>=ROCHE OMNI S6 SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJC·April 29, 2013
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·September 11, 2014
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·April 12, 2011
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018