30 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004042·PowerChem Neoprene Exam Gloves, Large
PC ECG 1200
FDA 510(k)
FDA Class 2
·Cardiovascular
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964003873·The ENDO CARRY-ON Procedure Kit contains all of...
PediFlex
FDA UDI
ORTHOPEDIATRICS CORP.·00841132133378·PEDIFLEX LID
Valeo Spacer System
FDA UDI
SINTX Technologies, Inc.·M555316000404·Base, Phantom Plus PLIF, TLIF System Case 1
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·August 23, 2024
LOCK BIPOL.SELF-CENT.HEAD Ø45
FDA Adverse Event
Malfunction
·LIMACORPORATE SPA·Product code LPH·July 25, 2019
PRIMEADVANCED
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LGW·March 12, 2013
9800
FDA Adverse Event
Death
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 16, 2011
UNK DEPUY SZ 4 KNEELED TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSH·February 19, 2008
Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04
FDA Recall
Terminated
·Gebauer Company·Product code MLY·April 17, 2007
CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·September 16, 2025
SMR SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code KWS·January 3, 2024
RUMI II KOH-EFFICIENT
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·February 15, 2024
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
FDA Recall
Terminated
·Liberty Medical Supplies·Product code FMF·February 24, 2003
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013