21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
FDA 510(k)
FDA Class 2
·Radiology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950026616·LATEX TUBING 1/4"X3/32" AMBER 50' RL NS W/L
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032960·Baltic Denture System BDLoad Mn6 PLSEbim6DFm C1...
Lingual Sheaths
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746156991·WELD LINGUAL SHEATH UR 036 SLOTTED R7M W/DIST I...
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
FDA 510(k)
FDA Class 2
·Hematology
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
FDA 510(k)
FDA Class 2
·Orthopedic
8.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
5.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV.·Product code BTR·September 17, 1999
5.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
8.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV.·Product code BTR·September 17, 1999
9.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
6.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
7.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
5.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
9.0MM HI LO
FDA Adverse Event
Malfunction
·MMJ SA DE CV·Product code BTR·September 17, 1999
TT BASIC HVLP TRACHEOSTOMY TUBE 6.0 MM
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·April 1, 2013
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·March 29, 2011
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Other
·STAAR SURGICAL CO.·Product code HQL·April 22, 2008
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 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