26 results
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19ms
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Sources: EU EUDAMED, US FDA
Neocis Guidance System (NGS) with Patient Splints
FDA 510(k)
FDA Class 2
·Dental
Zavation
FDA UDI
Zavation LLC·00842166131859·Ti3Z CIF 12mmx14mmx5mm -8 deg
COTTLE-DORSAL SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055766·COTTLE-DORSAL SCISSORS SERRATED BLADES POWER CU...
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930669·BIT, CRUCIFORM 6.0MM AO
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361021070·12x15 Arena-C HA PEEK Lordotic 5mm
Histofluor® Rodent LKS Fluorescent Antibody Test System
FDA UDI
IMMUNO CONCEPTS INC·M7491200805101·Rat KS 8 Well Tissue Slides - 10 Slides
GALLERY LAMINOPLASTY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KAVO K.E.Y. LASER 1242
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069724806·Widex D-CIC (Light beige S-110 ) Left, RC coil
Widex
FDA UDI
Widex A/S·05706069725162·Widex EVOKE E-IP (Light beige S-110 ) Right
Widex
FDA UDI
Widex A/S·05706069725766·Widex EVOKE E-CIC (Light beige S-110 ) Left, RC...
Widex
FDA UDI
Widex A/S·05706069724448·Widex UNIQUE U-CIC L (Light beige S-110 ) Left,...
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 2, 2009
TRULIANT TIB IMP PS INSERT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 18, 2023
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 28, 2018
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·October 24, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 1, 2013
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
FDA Recall
Terminated
·Cook Endoscopy·Product code KOG·April 20, 2006