12 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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X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
FDA 510(k)
FDA Class 2
·Dental
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867237·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND CLOSED...
PET DOSE DRAWING SYSTEM
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175004661·Dose Drawing System, PET
ACTICOAT COMPOSITE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
BIS/EEG MODULE
FDA 510(k)
FDA Class 2
·Neurology
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 21, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 9, 2013
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·October 30, 2013
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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