28 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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APNEA RISK EVALUATION SYSTEM (ARES)
FDA 510(k)
FDA Class 2
·Anesthesiology
Biosens cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110501648·box of 6 identical cartridges sealed in a vacuu...
T-Crystal cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110500245·Box of 6 identical cartridges sealed in aluminu...
8230 BALLOON CONTROLLER
FDA UDI
HANS RUDOLPH, INC.·00874750008964·8230 INFL-2 BALLOON CNTRL 115V
Disc Prep
FDA UDI
Life Spine, Inc.·00190837089986·
Driver
FDA UDI
ELLIQUENCE, LLC·00846338002176·
T-Crystal cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110506148·5 identical cartridges sealed in a vacuum bag ;...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180512340·ALIF, Modular Rasped Rotating Distractor, Tip, ...
Oxy2Mask™
FDA UDI
Southmedic Incorporated·10620974003516·O2 Kid Mask with 14ft tubing
OxyKid™
FDA UDI
Southmedic Incorporated·10620974000164·OxyKid Pediatric Mask with 14ft tubing
OxyPlus™
FDA UDI
Southmedic Incorporated·10620974000386·OxyPlus Large Mask with 14ft tubing
OxyMask™
FDA UDI
Southmedic Incorporated·10620974000256·OxyMask with 14ft tubing
Oxy2Mask™
FDA UDI
Southmedic Incorporated·10620974003530·O2 Plus Mask with 14ft tubing
Oxy2Mask™
FDA UDI
Southmedic Incorporated·10620974003523·O2 Adult Mask with 14ft tubing
STEELEX STE SET 6 (8) 4X45CM HRS48
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAQ·February 7, 2014
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIGIPAN / DPI
FDA 510(k)
FDA Class 2
·Dental
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105885·3.5mm Locking Medial Distal Tibial Plate, 6 Hol...
OxyMask O2 Adult REF OM-1125-14
FDA Enforcement
Class II
·Ongoing·Southmedic, Inc.·August 4, 2021