13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
O-Cryl Self Curing Acrylic Shade Clear X 1 lb
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126626343·O-Cryl Self Curing Acrylic Shade Clear X 1 lb
OneTouch Verio Flex
FDA UDI
LifeScan Europe GmbH·00353885010719·OneTouch Verio Flex Blood Glucose Monitoring Sy...
STACKHOUSE LENS HOOD, MODEL SA-700/FS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNIMARK HCG COMBO PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
S-LOK POLYAXIAL SCREW
FDA Adverse Event
Malfunction
·T AND S MACHINE SHOP, INC.·Product code MNI·February 27, 2013
LAMITRODE TRIPOLE 16 LEAD, 60 CM
FDA Adverse Event
Death
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 16, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 18, 2021
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 30, 2011
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
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