16 results · 23ms · Sources: EU EUDAMED, US FDA

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ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RUSCH

FDA UDI
TELEFLEX INCORPORATED·04026704319565·SLICK SET CUFFED STERILE

SCOVILLE LUMBAR BLADE

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896037748·SCOVILLE LUMBAR BLADE

OsteoMed

FDA UDI
OSTEOMED LLC·00845694004626·SpectrumTM Large Horizontal Bow

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Enforcement
Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889981168728·CORTICAL SHANK, Cannulated, 7.0 X 65

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889987168722·CORTICAL SHANK, Cannulated, 7.0 X 65

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

SPAULDING IQ ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

AMS SINGLE INCISION SLING SYSTEM (SIS-0)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MINICAP TRANSFER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 14, 2013

POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)

FDA Adverse Event
Injury ·AVENTIS PHARMA GRUPPO LEPETIT S.R.L.·Product code LMH·July 13, 2011

COMPLETE MULTI-PURPOSE

FDA Adverse Event
Other ·ADVANCED MEDICAL OPTICS INC.·Product code LPN·September 21, 2008

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065

FDA Recall
Open, Classified ·TELEFLEX LLC·Product code BTR·May 25, 2023

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065

FDA Enforcement
Class I ·Ongoing·TELEFLEX LLC·July 5, 2023

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012