14 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371066·STRETCHER PAD 28" W X 2" H X 74" L STANDARD
ORTHO ORGANIZERS, INC.
FDA registration
ORTHO ORGANIZERS, INC.·40 products·🇺🇸 United States
PERFORMER 30 HPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·December 4, 2020
HOSPITAL NON-VENTED FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
28MM M2A MODULAR HEAD +6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 26, 2013
TRIAGE CARDIAC PROFILER KIT
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code MMI·April 28, 2011
REPIPHYSIS DISTAL FEMUR
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KRO·July 24, 2008
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024