11 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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ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032464·Baltic Denture System BDLoad Mm6 PLSEbim6DFm B4...
HELIX HYDRO-JET
FDA 510(k)
FDA Class 2
·General Hospital
SMITH & NEPHEW OFF-CENTERED PORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
9611993-2022-032464
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·January 11, 2022
DEPUY ASR XL FEM IMP SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013
ITREL 3
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·March 25, 2011
POWER PRO AMBULANCE COT
FDA Adverse Event
Other
·STRYKER CORP - MEDICAL DIV·Product code FPO·April 16, 2008
MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code MBI·May 20, 2020
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 Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016