14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
FDA 510(k)
FDA Class 2
·Anesthesiology
Cetro America Ultrasound Transducer for IM76/AM66, Waterproof
FDA UDI
CETRO AMERICA INC·00852519007083·Waterproof Ultrasound Transducer for Advanced M...
NORTH AMERICA MATTRESS CORP.
FDA registration
NORTH AMERICA MATTRESS CORP.·1 product·🇺🇸 United States
InTess L
FDA UDI
Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square
Arlington PLIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215026318·
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742121932·DRACO MetaFuse Midfoot/Lisfranc Plate, Ti - (L)...
Verteloc Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129316·
FORTAFLEX SURGICAL SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
FDA 510(k)
FDA Class 2
·Anesthesiology
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 28, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·March 10, 2011
GE OEC 9800
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013