17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
FDA 510(k)
FDA Class 2
·Orthopedic
Reusable Tubular Temperature Probe
FDA UDI
MEASUREMENT SPECIALTIES, INC.·H2974060·.125” dia. S. S. Tubular Reusable Temperature P...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609584·BERCHTOLD 3.25" SOFTCARE PLUS
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
STONELITH, MODEL V5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
FDA 510(k)
FDA Class 2
·General Hospital
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
IRE SINGLE ELECTRODE PROBE
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code OHJ·April 7, 2010
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 6, 2024
IRE SINGLE ELECTRODE PROBE
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code OHJ·April 7, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013
MASIMO PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·August 29, 2014
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·April 14, 2011
IRE SINGLE ELECTRODE PROBE
FDA Adverse Event
Death
·ANGIODYNAMICS·Product code OHJ·April 9, 2010
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''
FDA Recall
Terminated
·Medex Inc·Product code GWM·November 18, 2005
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