15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HANSON MEDICAL CALF IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hern Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030808·Hern Dilator 44Fr (14.6 mm)
Vario
FDA UDI
Ropox A/S·05707581000560·
MiroDerm Fenestrated Plus
FDA UDI
REPRISE BIOMEDICAL, INC.·00857072005248·8 x 8 cm Fenestrated Plus Biologic Wound Matrix
TAKE 1
FDA 510(k)
FDA Class 2
·Dental
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
PRISM NUCLEAR GAMMA CAMERA SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code KPS·March 27, 2013
MICRO INTRODUCER SHEATH SET
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES, INC.·Product code DRE·March 22, 2011
PRO OSTEON 500
FDA Adverse Event
Malfunction
·EBI, L.P.·Product code MBS·April 17, 2008
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
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