21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011132801000·Grinding points, pink, medium hardness, coarse ...
K133801
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024
ADVIA Centaur® Cuvettes
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD
PHTIP DISPOSABLE ISFET CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
PENTA
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 29, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2011
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PKL·July 19, 2021
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022
CAPIOX FX15
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·July 5, 2023
CAPIOX CUSTOM PACK
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·April 2, 2024
CAPIOX FX05
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 26, 2023
Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711. Part # SP-1328-01 Lot 968720 Qty 34 10/6/2005. Sold for use with: Part # SP-1598-13 Lot # 041950 Qty 10. Part # SP-1597-13 Lot # 066720 Qty 9. Part # SP-1598-13 Lot 050140 Qty 15. Product Usage: Distraction devices are for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxiollofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb resorbable correction plates, which are implanted by fixation with LactoSorb bone screws.
FDA Recall
Terminated
·Walter Lorenz Surgical, Inc.·Product code JEY·February 17, 2006
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026