18 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MiniKut
FDA UDI
DENTAL ENGINEERING LABORATORIES, LLC·00850001745420·MiniKut Rotary NiTi Endodontic Files .25/.05, 2...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848601·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...
Expert
FDA UDI
C A I INDUSTRIES CORP·00807689005384·0.25x25mm acupuncture needles.
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
FDA 510(k)
FDA Class 2
·Hematology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 11, 2011
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 22, 2008
CORIN METAFIX HIP STEM
FDA Adverse Event
Injury
·CORIN MEDICAL·Product code LZO·September 6, 2022
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
BACT/ALERT® SA CULTURE BOTTLE
FDA Adverse Event
Injury
·BIOMERIEUX INC.·Product code MDB·August 16, 2019
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
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