12 results
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20ms
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Sources: EU EUDAMED, US FDA
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
FDA 510(k)
FDA Class 2
·Radiology
Safco Flexible Files
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310243543·Safco flexible files #25 25mm 6/box
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120243541·Carbide, round, bone cutter
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 14, 2012
ULTRAGUIDE CTG 2000SA
FDA 510(k)
FDA Class 2
·Radiology
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 28, 2025
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 27, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 18, 2011
SLIMLOC SCREW 14MM
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code KWQ·April 3, 2008
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 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