16 results
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27ms
·
Sources: EU EUDAMED, US FDA
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
FDA 510(k)
FDA Class 2
·Neurology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293500·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049675·Steinmann Pins, Single trocar, 3 shank end, 7/6...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771013075·Steinmann Pins, Single trocar, 3 shank end, 7/6...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484894·Steinmann pin w. trocar/3-shank _x000D_...
Steinmann pin w. trocar/3-shank 2.8mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM714860·Steinmann pin w. trocar/3-shank
2.8mm/...
Q-RAD RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GENX CODA AIR PURIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 22, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 15, 2011
CONTOUR TEST STRIPS (10)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 2, 2008
135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2H-STER
FDA Adverse Event
Malfunction
·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code KTT·January 19, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012