17 results
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32ms
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Sources: EU EUDAMED, US FDA
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389000755·CIRCUIT-ADULT ANESTHESIA
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389005477·CIRCUIT-ADULT ANESTHESIA
Soft-Form™ Thermo Plastic External Nasal Splint
FDA UDI
INVOTEC INTERNATIONAL, INC.·00818501022618·Soft-Form™ Thermo Plastic External Nasal Splint...
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389000830·CIRCUIT-ADULT ANESTHESIA
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389000724·CIRCUIT-ADULT ANESTHESIA
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
FDA 510(k)
FDA Class 2
·Clinical Toxicology
V40 COCR LFIT HEAD 40MM/+12
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 19, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 1, 2011
ON-Q C-BLOC
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·March 7, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 20, 2014
BIODESIGN URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTM·July 29, 2013
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 16, 2016
CONMED BEND-A-BEAM ABC HANDPIECE
FDA Adverse Event
Injury
·CONMED ELECTROSURGERY·Product code GEI·July 16, 2002
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
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