21 results
·
27ms
·
Sources: EU EUDAMED, US FDA
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
FormaGraft
FDA UDI
Nuvasive, Inc.·00887517238450·FormaGraft® XL Blocks, Small
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033142820·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033142837·
6.5 Cancellous Bone Shaft Screw, hex, St.Steel, L 85/16 mm
FDA UDI
mahe medical gmbh·EMAH00100100850·6.5 Cancellous Bone Shaft Screw, hex,
St.Ste...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659173392·6.5 Cancellous Bone Shaft Screw, hex, _x000D_...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033142813·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033142844·
10 x 85mm Anodized SI Implant
FDA UDI
Osteocentric Technologies, Inc.·00810097800151·10 x 85mm Anodized SI Implant
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521010085D0·10 x 85 mm Anodized SI Implant
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100050·Tap, 6.5mm Cann, Quarter Square
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTSETT
FDA 510(k)
FDA Class 2
·General Hospital
CELSITE ACCESS PORT
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·November 20, 1997
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 11, 2011
VP 2000 PROCESSOR
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code KEY·December 17, 2010
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