23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTEP-ASSR, MODEL M811007
FDA 510(k)
FDA Class 2
·Neurology
Cetro America Ultrasound Transducer 1.150MHz, for Sonomed with blue lemo conne
FDA UDI
CETRO AMERICA INC·00852519007236·Replacement Ultrasound Transducer 1.150MHz, for...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607000555·Mission Urinalysis Reagent Strip (GLU/KET/PRO/P...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607000562·Mission Urinalysis Reagent Strips (GLU/PRO/NIT/...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607000586·Mission Urinalysis Reagent Strip (BIL/URO/LEU/N...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607000579·Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607200313·Mission Urinalysis Reagent Strip (BIL/URO/LEU/N...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607200283·Mission Urinalysis Reagent Strip (GLU/KET/PRO/P...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607200306·Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH...
Mission Urinalysis Reagent Strips
FDA UDI
Acon Laboratories, Inc.·00682607200290·Mission Urinalysis Reagent Strips (GLU/PRO/NIT/...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated
RX EVEREST
FDA 510(k)
FDA Class 2
·Dental
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 5, 2025
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 28, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·March 16, 2011
GE OEC 2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016