15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRELLIS-6 PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
KEY SURGICAL, INC.·10849771052361·Steinmann Pins, Single diamond, round end, 2.0m...
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
FDA 510(k)
FDA Class 2
·Cardiovascular
IMAGER II ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 18, 2024
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWA·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
ACCESS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code DRB·April 22, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·April 15, 2011
PERMANENT CAUTERY HOOK INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·July 8, 2008
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026