26 results · 19ms · Sources: EU EUDAMED, US FDA

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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