12 results
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20ms
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Sources: EU EUDAMED, US FDA
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
Safco Surgical Length Bur
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310234553·Safco surgical length bur, #6 round FG, 5-pack
ES™ TROCHANTERIC NAIL, RIGHT, Ø11mm x 45cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014570·
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
FDA 510(k)
FDA Class 2
·Anesthesiology
TISSUEMEND SOFT TISSUE REPAIR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMR SHOULDER SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·April 8, 2026
UNKNOWN_MEDICAL_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 8, 2011
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·April 2, 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
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018