16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00141021·
Hanau modular Articulator
FDA UDI
WHIP-MIX CORPORATION·D0400141020001·A dental articulator is a device designed to si...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140020·Driver Shaft, T30 No Taper, Final Cap Driver
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033569306·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0140020·Driver Shaft, T30 Final Cap, MIS
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0140120·Guide, Anti-Splay
SONIC MODEL SO-300
FDA 510(k)
FDA Class 2
·Physical Medicine
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
LUCAS (T) CPR CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB·Product code DRM·July 1, 2014
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
CARPENTIER EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code KRH·March 12, 2008
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