23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
FDA 510(k)
FDA Class 2
·General Hospital
Batrik Blue Cloud-Gel Anti-Fatigue Floor Mats
FDA UDI
Batrik Medical Manufacturing Inc·00690521011618·Blue Cloud-GelTM Anti-Fatigue Mat, 18" x 24" (4...
START VPS
FDA UDI
DANVILLE MATERIALS, LLC·00816594021297·START VPS,HEAVY,STF,BITE,KIT 2
JOBST Custom Seamless Soft
FDA UDI
BSN-Jobst GmbH·04059993125708·CUSTOM SEAMLESS SOFT 1/CHAP STYLE/OPEN TOE/CRAN...
4.0 X 24mm CANN SCREW FASTENER Ti SH THD
FDA UDI
Osteocentric Technologies, Inc.·00810074303057·4.0 X 24mm CANN SCREW FASTENER Ti SH THD
JOBST Custom Seamless Soft
FDA UDI
BSN-Jobst GmbH·04059993143252·CUSTOM SEAMLESS SOFT 2/CHAP STYLE/OPEN TOE/CRAN...
Powered Loading System (PLS) (Component)
FDA UDI
LIFEPORT, LLC·00810050861854·RAIL ASSEMBLY, GLOBAL * (PLS)
NEEDLE SFTYGLD 27X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·June 29, 2020
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945700024010·Shoulder Strap-Black
Compumedics Quik-Cap
FDA UDI
COMPUMEDICS LIMITED·09342451006035·Quik-Cap Neoprene Flexnet - Grael 128 Ch Xlarge
AMT THERAPEUTIC TABLE, MODEL 748AMT
FDA 510(k)
FDA Class 2
·Physical Medicine
VAPOTHERM, MODEL 2000I
FDA 510(k)
FDA Class 2
·Anesthesiology
BD SAFETYGLIDE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·July 9, 2020
SURGITEK REPLICON SILICONE BREAST IMPLANT
FDA Adverse Event
Malfunction
·MEDICAL ENGINEERING CORP.·Product code FTR·June 8, 1994
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 10, 2014
PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·March 8, 2013
THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·January 28, 2011
CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2022
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025