14 results
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19ms
·
Sources: EU EUDAMED, US FDA
VSTAAR AdjusteR
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
MAKO SURGICAL CORP.·00848486020576·ACETABULAR REAMER ¿ 59mm
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017804·K-Wire, Double Ended, Trocar Point, Diameter Si...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044990·Unitek(TM) Molar Band General Purpose Narrow Re...
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290716·Denovo general purpose dental molar band - Mand...
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
FDA 510(k)
FDA Class 2
·Cardiovascular
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
FDA 510(k)
FDA Class 1
·Dental
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 31, 2022
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG.·Product code DXY·June 10, 2013
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 2, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024