13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
FDA 510(k)
FDA Class 2
·Microbiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994455765·CASE 6191931 A TRANS SHRT PLT CADDY LID
Sklar
FDA UDI
SKLAR CORPORATION·10649111452031·RAMSAY FORCEPS SERRATED 1X2 7 INCHES
NONDISPOSABLE STIMULATING INSTRUMENTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GLIASITE RTS
FDA 510(k)
FDA Class 2
·Radiology
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 1, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 22, 2011
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·September 3, 2014
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026