151 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Silatrix Oral Gel
FDA 510(k)
FDA Unclassified
·Unknown
RESPI-CHECK ADULT BREATHING INDICATOR HIGH CONCENTRATION OXYGEN MASK WITH TUBE
FDA UDI
Intersurgical Incorporated·05030267051991·RESPI-CHECK™, ADULT, BREATHING INDICATOR HIGH C...
DOUBLE-J
FDA UDI
Gyrus ACMI, LLC·00821925006164·6.0FR(2mm) X 16 cm SURGITEK DOUBLE-J CLOSED TIP...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007306·2.0mm MMF Auto-Drive Screw M4 Organizer
SRS PROFILER
FDA UDI
SUN NUCLEAR CORP.·05060608880089·Radiotherapeutic quality assurance instrument
Monkey Rings™ External Fixation System
FDA UDI
Paragon 28, Inc.·00889795116505·Pin Cutter
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641509·Semi-automatic Disposable Biopsy Needle
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 27, 2014
iTotal PS
FDA UDI
Conformis, Inc.·M572RPS0202000121·ITOTAL PS IPOLY XE - 20MM INSERT - RIGHT or lef...
iTotal Identity CR
FDA UDI
Conformis, Inc.·M572RCR0202000141·ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPO...
iTotal Identity Posterior Stabilized Knee Replacement System
FDA UDI
Conformis, Inc.·M572RPS0202000031·ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY...
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641585·Semi-automatic Disposable Biopsy Needle
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641660·Semi-automatic Disposable Biopsy Needle
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS;
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADULT STAR MODEL 1202000
FDA Adverse Event
Injury
·NELLCOR-PURITAN BENNETT, INC.·Product code CBK·December 15, 1999
Coselgi
FDA UDI
Widex A/S·05706069666083·Coselgi C-tune II V2.4 DVD
ERBE APC
FDA Adverse Event
Injury
·ERBE USA, INC.·Product code GEI·April 18, 2000
PACESETTER
FDA Adverse Event
Injury
·PACESETTER ST JUDE MEDICAL·Product code DXY·April 28, 2000
AESTIVA 3000
FDA Adverse Event
Malfunction
·DATEX-OHMEDA·Product code BSZ·October 26, 2000