14 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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AOR-SULLIVAN PROTECTIVE OVERGLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428251966·Hydrocolloid Gel Adhesive Pads, all one size, 3...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198116·AK3 PS Insert Trial Size 1, 18mm
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331164057·bunnell tendon stripper, round, 6" (15.0 cm), 7...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867131798·QUICKFIX SCREW, 3 X 18 MM
BRAINLAB KNEE ARTHROSCOPY
FDA 510(k)
FDA Class 2
·Neurology
TGS Guidewire and updated Scopis Software
FDA 510(k)
FDA Class 2
·Neurology
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·December 22, 2009
INFANT NASAL MASK
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BYG·June 25, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·October 29, 2010
PFC SIGMARP CV TB/IN S5 10.0
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·January 2, 2013
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 25, 2023
Presource PBDS, Shoulder Procedure, Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025