14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DC-IN CABLE
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415906191·
ZOLL AED PLUS
FDA 510(k)
FDA Class 3
·Cardiovascular
ACCU-CHEK AVIVA SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
IMPLANT SPS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·April 11, 2013
TOTAL CARE SPORT BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 17, 2011
CERAMTEC CERAMIC INS/SLEEVE TRIDENT G
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code MEH·May 28, 2008
ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·November 21, 2018
ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWT·November 21, 2018
ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
BACT/ALERT® SA CULTURE BOTTLE
FDA Adverse Event
Injury
·BIOMERIEUX INC.·Product code MDB·August 16, 2019
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