19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIRBLANK-PS AND ZIRBLANK-FS
FDA 510(k)
FDA Class 2
·Dental
Vari-Simplex - TMA
FDA UDI
ORMCO CORPORATION·00889989026603·ARCH ALEXAND TMA UPPER 016X022 PK/10
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114690300·Open Tray MU/SU Impression Coping Screw, UNF 1-...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690583·Titanium Anatomic Straight Concave Abutment In...
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981166229·CORTICAL SHANK, SOLID, 7.0 X 45
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987166223·CORTICAL SHANK, SOLID, 7.0 X 45
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802003·Crile-Rankin Hemostatic Forceps, Curved, 16cm
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
FDA 510(k)
FDA Unclassified
·Unknown
POSITUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
VertebraLINK
FDA UDI
LINKSPINE, INC.·00817329025139·Long Nerve Root Retractor
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 23, 2026
PEN NDL 31GA 5MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·August 23, 2024
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·April 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·July 3, 2008
BENCHMARK GX, STAINER MODULE
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 12, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·July 19, 2020
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024