19 results
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35ms
·
Sources: EU EUDAMED, US FDA
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
FDA 510(k)
FDA Class 2
·Cardiovascular
ERA 2.2MM IMP 0DEG MICRO HEAD 13X1MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108532·Designed for both transitional and long-term de...
Printed Lower ROC Pack for Herbst LL8 12mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015840·
ASNIS
FDA UDI
Stryker GmbH·04546540132062·Plastic Lid
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083014834·Fixed, 10 electrode, MPA, 5-5-5-24-3-3-3-3-3mm ...
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP)
FDA Adverse Event
Malfunction
·AVANOS MEDICAL - IRVINE·Product code MEB·May 17, 2019
TRANSEND EX 14 GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQX·September 23, 2009
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT
FDA 510(k)
FDA Class 2
·Ophthalmic
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.,·Product code CBK·May 7, 2014
ABGII, MODULAR STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 3, 2013
TRIDENT PSL HA CLUSTER 50MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 12, 2010
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