16 results
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28ms
·
Sources: EU EUDAMED, US FDA
CUFFALERT
FDA 510(k)
FDA Class 2
·Anesthesiology
Mictec Crile Wood Needle Holder
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896111240·Mictec Crile Wood Needle Holder With Ratchet Tu...
SEAL & PROTECT PROTECTIVE SEALANT
FDA 510(k)
FDA Class 2
·Dental
BLU-U, MODEL 4170
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 29, 2022
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 6, 2026
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY·Product code GEX·April 4, 2011
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·July 23, 2008
Axiom Artis MP X-Ray System
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·April 1, 2005
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018