14 results
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18ms
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Sources: EU EUDAMED, US FDA
SUNPEX TECHNOLOGIES MODEL SE03
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033019·Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs C...
ELMED
FDA UDI
ELMED INCORPORATED·00842180184510·MICRO SCISSORS, STRAIGHT, 18.5CM
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
Cosmolock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm
DATACAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NA
FDA UDI
Zimmer, Inc.·00889024114197·
DXTEND GLENOSPHERE ECC D42MM
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code HSD·April 3, 2013
CONSERVE(R) TOTAL A-CLASS HEAD
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JDL·August 25, 2014
NONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION·Product code HCG·April 22, 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
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