18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
AXIOM BIOLASER LLLT SERIES-3
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033015·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm C...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319718032·Hayden Dermal Curette 6-1/4" (15.6cm), oval spo...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811050·Keyes Dermal Biopsy Punch, Stainless Steel, 5mm
Omnicurve
FDA UDI
STRYKER CORPORATION·07613327638226·10G 15MM EXTRA LEVEL
CARDIS
FDA 510(k)
FDA Class 2
·Cardiovascular
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEAD MODEL 304
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 4, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 25, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NQP·April 22, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021