12 results · 20ms · Sources: EU EUDAMED, 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