13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
FDA 510(k)
FDA Class 2
·General Hospital
TruLock
FDA UDI
Rmo, Inc.·00885797658289·TRULOCK Light Activated Adhesive Kit (4ea Syrin...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312520·HUMELOCK REVERSED SUPERIOR LATERAL CUTTING GUIDE
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989026429·ARCH ALXLOOP TMA 17X25 L/U 42MM PK/5
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL 455GE PHASED ARRAY WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
NI
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·April 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 15, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2008
BUTTRESS/COMPRESSION NUT FOR 357.369
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HST·April 6, 2016
BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·April 6, 2016
NON-VENTED HOSPITAL FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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