16 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DRESSING CHANGE SET CAT.#910-930
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Two Striper
FDA UDI
ABRASIVE TECHNOLOGY, INC.·B868C8020171·Dental Root Canal Post
Vista Straw Aspirator Kit
FDA UDI
Vista Dental·10818207021592·
Forcep
FDA UDI
KOROS U.S.A., INC.·10840199533791·Micro Round Handle Forcep Straight Platform 17....
Raw Surgical Corporation
FDA UDI
RAW SURGICAL CORPORATION·G508RSC08020170·LILEHEI-POTTS TENOTOMY SCISSORS, Curved, Overal...
ACUMED
FDA UDI
Acumed LLC·10806378089817·Osteotomy Saw Blade Hub Style DS
STARR FRAME STEINMANN PIN
FDA 510(k)
FDA Class 2
·Orthopedic
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NON VENTED HIGH VOL.INLET,N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ¿ ROUND LAKE·Product code LHI·January 30, 2019
KANGAROO EPUMP - NEW
FDA Adverse Event
Malfunction
·COVIDIEN·Product code LZH·July 22, 2016
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDI·May 9, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 23, 2012
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2010
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013