17 results
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20ms
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Sources: EU EUDAMED, US FDA
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033016·Baltic Denture System BDLoad Mw6 PLSEbim6DFm C3...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position
Universa
FDA UDI
COOK INCORPORATED·00827002532410·Universa, Silicone Foley Catheter 3-Way Open End
Universa
FDA UDI
COOK INCORPORATED·00827002530300·Universa, Silicone Foley Catheter 3-Way Closed End
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811074·Keyes Dermal Biopsy Punch, Stainless Steel, 6mm
PRO-FEMUR R
FDA 510(k)
FDA Class 2
·Orthopedic
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
ASR ACETABULAR IMPLANT 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·August 25, 2014
PC PALINDROME 23/40 KIT W/SLOT
FDA Adverse Event
Death
·TYCO HEALTHCARE/KENDALL·Product code MPB·April 22, 2008
TRANSRAY PLUS 7.5FR. 35CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·May 20, 2024
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021