20 results
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34ms
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Sources: EU EUDAMED, US FDA
FINGER PAINGUARD CAT.#193-194
FDA 510(k)
FDA Class 1
·General Hospital
NA
FDA UDI
Richard Wolf GmbH·04055207008843·UNIVERSAL CAP FOR BRONCH. reusable
Bardia® Universal Catheter Insertion Tray
FDA UDI
C. R. Bard, Inc.·00801741051159·Bardia Universal Catheter Insertion Tray, 10 cc
Vista Short High Volume Aspirator 9.5 x 6.5 mm
FDA UDI
Vista Dental·10818207021578·
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18020151·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482032268·Symmetry® Scissors, Micro, Straight, Sharp/Shar...
OSTEON, OSTEON SINUS, OSTEON LIFTING
FDA 510(k)
FDA Class 2
·Dental
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Dermatome
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024375970·Dermatome 1.5" Width Plate
EASYTOUCH
FDA Adverse Event
Malfunction
·BERPU MEDICAL TECHNOLOGY CO., LTD·Product code FMF·March 23, 2023
EASY TOUCH
FDA Adverse Event
Malfunction
·MHC MEDICAL PRODUCTS, LLC·Product code FMF·May 27, 2022
URINARY DRAINAGE BAGS
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code FCN·February 12, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 23, 2012
BASAL/BOLUS INFUSOR 2 X 2 (15MIN LOCKOUT)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 16, 2010
ACUVUE OASYS FOR ASTIGMATISM, +6.00, -1.75 180, 2015/04
FDA Adverse Event
Injury
·JOHNSON & JOHNSON·Product code LPL·August 29, 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
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
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