71 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DERMATOLOGICAL TREATMENT DEVICE FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sonopal® hard Lacquer Al
FDA UDI
Innovation MediTech GmbH·E239M1113031·No.
SOLENT DISTA
FDA UDI
Bayer Healthcare LLC·00616258005089·SOLENT DISTA, FG PKG
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118357·LOCATOR R-Tx Abutment For 5.0mm Premium Implant...
Life Instruments
FDA UDI
Life Instrument Corporation·M930711130310·Ring Curette #3 angled
Life Instruments
FDA UDI
Life Instrument Corporation·M930711130300·Ring Curette 13" #3 str.
K2M General Instruments
FDA UDI
VB Spine LLC·10888857530980·Trial Size 12x14x7 mm, 6°
STRATUS CS ACUTE CARE D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
RANDOX PHENOBARBITAL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DXE·July 31, 2015
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
SYMBIOS GOPUMP
FDA Adverse Event
Injury
·SYMBIOS MEDICAL PRODUCTS·Product code MEB·May 9, 2013
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·August 19, 2015
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
TL PEDICLE SCREW DIA. 6,5 LG 50
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·July 9, 2019
TL PEDICLE SCREW DIA. 6,5 LG 50
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·July 9, 2019