6,379 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ITW FILTERTEK
FDA registration
ITW FILTERTEK·1 product·🇺🇸 United States
NA
FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544014638·Instrument, Torque Wrench, Surgical
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)
FDA registration
FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)·1 product·🇮🇪 Ireland
NA
FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544014614·Instrument, Torque Wrench
NA
FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544014645·Instrument, 100Ncm Bending Attachment, I-TWS
NA
FDA UDI
SOUTHERN IMPLANTS (PTY) LTD·06009544014652·Instrument, 45Ncm Bending Attachment, I-TWS
0808,APS1,08,N,LT,IT,W/BREAKAWAY
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828149426·0808,APS1,08,N,LT,IT,W/BREAKAWAY
MEDAPHENE SCRUBS DISINFECTANT DEODORANT WIPES
FDA Adverse Event
Other
·ITW DYMON·Product code LRJ·July 16, 2004
SEATBELT
FDA Adverse Event
Death
·ITW NEXUS·Product code KNN·January 20, 1995
FASTEQX SR-2
FDA Adverse Event
Injury
·ITW NEXUS·Product code KNO·September 5, 1995
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code LFL·June 1, 2012
BOSTON SCIENTIFIC PROMUS PREMIER 2.25 MM X 32 MM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code NIQ·July 29, 2014
ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.
FDA Recall
Terminated
·ITW Dymon·February 15, 2005
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 13, 2014
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 13, 2014
KII® BALLOON BLUNT TIP SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 19, 2025
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 13, 2014
BIOMET ECHO HIP
FDA Adverse Event
Malfunction
·BIOMET, INC.·Product code KWA·September 19, 2024
FLEXIVA ID
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·July 14, 2022
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·December 18, 2013