17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EXCELARREST FOAM
FDA 510(k)
FDA Unclassified
·Unknown
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108864·PIGTAIL PROBE WITH SUTURE HOLES
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702542233·ELVAREX FORTE 3/KNEE HIGH/CLOSED TOE-ELEPHANTIA...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702366631·Elvarex 3/Knee High/Profile-Open Toe/Dotted Sil...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702442359·Elvarex 4/Thigh High/Slant-Open Toe/Dotted 5 c...
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
FDA 510(k)
FDA Class 1
·Dental
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSO·April 30, 2020
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code BSO·April 30, 2020
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 5, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 29, 2011
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 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