23 results · 22ms · Sources: EU EUDAMED, 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