23 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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ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Oklahoma Gas & Electric - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588140780·Oklahoma Gas & Electric - 18 Metal
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033577424·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033577431·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01407N0·Cervical Rasp, 15 x 12, 7mm, 0 Degree, No Taper
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563052·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563069·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01407T0·Cervical Rasp, 15 x 12, 7mm, 7 Degree, Tapered
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033577448·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563076·
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
FDA 510(k)
FDA Class 1
·General Hospital
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
IDENTITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011
TWINFIX AB 5.0 SUTURE ANCHOR W/2 38" ULTRBRAID
FDA Adverse Event
Malfunction
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code MBI·March 14, 2008
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022
UNKNOWN PROGRIP MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·April 5, 2023
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Enforcement
Class II
·Terminated·ITC-Nexus Dx·February 12, 2014
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 18, 2015