11 results
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19ms
·
Sources: EU EUDAMED, US FDA
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
FDA 510(k)
FDA Class 2
·Neurology
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063750982·Sterile Single Use Burs - ISO Code 379-023SF
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
FDA 510(k)
FDA Class 2
·Anesthesiology
MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE)
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code LFG·April 1, 2024
TRULIGN TORIC POSTERIOR CHAMBER IOL
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code MJP·August 23, 2015
CHUCK WITH KEY/DRILL SPEED FOR TRAUMA RECON SYSTEM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWE·March 27, 2013
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·March 18, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
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