13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MiniKut
FDA UDI
DENTAL ENGINEERING LABORATORIES, LLC·00850001745345·MiniKut Rotary NiTi Endodontic Files .40/.03, 3...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034031·Baltic Denture System BDLoad BDLoad ↓ Mw6 PLSEu...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120340311·Diamond, round, coarse grit, green ring
NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES
FDA 510(k)
FDA Class 1
·Dental
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
FDA 510(k)
FDA Class 2
·Immunology
CERELINK ICP PROBE 1L M BOLT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·October 12, 2023
ACTIVA RC
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·June 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 3, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 30, 2011
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·April 24, 2008
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
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