20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
OX-SOX, MODEL C, D, E,
FDA 510(k)
FDA Class 1
·Anesthesiology
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0620000·Universal Removal Set
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993451982·CONFIDENCE 3/THIGH HIGH/SLANT-CLOSED TOE-HALUX-...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993472307·CONFIDENCE 1/THIGH HIGH/SLANT-CLOSED TOE-HALUX-...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702581577·ELVAREX 1/KNEE HIGH/CLOSED TOE/SOFTFIT-SLIPFORM...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993442546·CONFIDENCE 2/THIGH HIGH/SLANT-CLOSED TOE-HALUX-...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993083619·ELVAREX 2/BODY BAND WITHOUT LEG EXTENSION/BOTH...
SUPER 6
FDA 510(k)
FDA Class 2
·Dental
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·December 17, 2025
EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·December 17, 2025
CONFIDENCE KIT, NO NEEDLES
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
POLY G-OMCP-VISUB-CCD (H5000)
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·March 18, 2011
CUSTOM COMBI SET
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FJK·June 18, 2008
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015