12 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TWINFIX FT PK
FDA 510(k)
FDA Class 2
·Orthopedic
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
TWINTRODE ELC 134 ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 10, 2021
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code FYD·April 23, 2013
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·April 29, 2011
MARQUIS DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008
NFLEX CURVED ROD 60MM-STERILE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code NQP·March 31, 2016
NCB PP PR FEM PLT L15H L324MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·April 3, 2025
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
FDA Recall
Open, Classified
·Ethicon, Inc.·Product code GAM·March 8, 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018