15 results
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22ms
·
Sources: EU EUDAMED, US FDA
Knee+
FDA 510(k)
FDA Class 2
·Neurology
WalkMed Infusion
FDA UDI
WALKMED TECHNOLOGIES, LLC·00859695006084·FPS-600 Pump tubing set with 0.2 micron filter ...
Impact™
FDA UDI
B BRAUN INTERVENTIONAL SYSTEMS, INC·04046964291241·IMPACT 20MMX2CMX75CM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112861·CORNEAL TREPHINE BLADE6.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112458·BARRON VACUUM TREPHINE 6.0MM
HL168T
FDA 510(k)
FDA Class 2
·Cardiovascular
PLV CONTINUUM VENTILATOR, MODEL P1000
FDA 510(k)
FDA Class 2
·Anesthesiology
MESH-COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 2, 2013
JUGGERKNOT 1.0MM MINI 2-0 NEEDLES
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·October 9, 2017
JUGGERKNOT 1.0MM MINI 2-0 NEEDLES
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·October 9, 2017
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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