11 results
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19ms
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Sources: EU EUDAMED, US FDA
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DOLPHIN GRASPING FORCEP INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012260·DOLPHIN GRASPING FORCEPS WITH RESERVOIR DOUBLE-...
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420170200·
KONG-TL VBR, End Plate, round, S and Screw, 12° x 26 mm
FDA UDI
icotec AG·07640164847580·KONG-TL VBR, End Plate, round, S and Screw, 12°...
AUDIT MICROCV RF/CRP LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·January 8, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·November 17, 2010
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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019