13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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'RAPID ONE' - PROPOXYPHENE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Hegar Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030835·Hegar Dilator 9-10mm
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308350·10mm Funnel
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20308351·BioStarter wires Straight-Arch-F. max. .014"
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JAS MAGNESIUM REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
LAP-BAND ADJUSTABLE BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·March 28, 2013
ICEMAN THERAPY UNIT
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code ILO·March 21, 2011
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code KRH·April 17, 2008
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
Single Shot Epidural Tray Catalog Number: 6797R2
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
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