18 results
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21ms
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Sources: EU EUDAMED, US FDA
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
FDA 510(k)
FDA Class 2
·Physical Medicine
Valencia Pedicle Screw System
FDA UDI
Altus Spine, LLC·00843210134710·5.5mm Pedicle Tap, Cannulated
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105514R1·IN-OVATION® mini Rhodium Base Rx 018 UL/5-5 CS ...
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055241·IN-OVATION® mini Base Rx 022 UL/5-5 CS BC HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523P1·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK PSV
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055131·IN-OVATION® mini Base Rx 018 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055231·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105524R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS B...
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 4300 PSARRAY EEG ELECTRODE SET
FDA 510(k)
FDA Class 2
·Neurology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 26, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
V SERIES MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·May 11, 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