19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENHANCE-S PLUS H
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037306277·HUMELOCK REVERSED REAMER Ø16mm
Asnis
FDA UDI
Stryker GmbH·07613154578023·CANNULATED SCREW
T-plates,116mm/6 holes
FDA UDI
mahe medical gmbh·EMAH00200301160·T-plates,116mm/6 holes
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659181465·T-plates,116mm/6 holes _x000D_...
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
FDA 510(k)
FDA Class 2
·Radiology
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Widex
FDA UDI
Widex A/S·05706069656398·COMPASS GPS V2.3 package (English)
Widex
FDA UDI
Widex A/S·05706069656404·COMPASS GPS V2.3 package (German)
Widex
FDA UDI
Widex A/S·05706069656428·COMPASS GPS V2.3 package (Spanish)
Widex
FDA UDI
Widex A/S·05706069656411·COMPASS GPS V2.3 package (French)
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·Product code LZG·April 2, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 26, 2011
REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWQ·April 14, 2008
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 6, 2021
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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