23 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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iSurg
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Polysorb
FDA UDI
Covidien LP·20884521126616·Absorbable Single Stitch Reload
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691016·Titanium Straight Single-Unit Abutment Internal...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
FDA 510(k)
FDA Class 2
·Neurology
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
25 GA POSTERIOR WIDE-FIELD ELITE PACK
FDA Adverse Event
Malfunction
·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019
PROMOTE RF CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
TRIATHLON PKR BASEPLATE #2 RM/LL
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HRY·July 13, 2011
FEELER F/SCR-CHANNEL CURV Ø2.3 L275
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXB·June 14, 2013
STELLARIS POWER SUPPLY II
FDA Adverse Event
Malfunction
·BAUSCH + LOMB·Product code HQC·August 1, 2023
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 8MM (5/16") U-100 100COUNT
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·June 6, 2025
HEMOSIL ACUSTAR HIT-IGG (PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·April 8, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 10888628032835, Natrelle Inspira SSM 175cc BI (US) 10888628032842, Natrelle Inspira SSM 195cc BI (US) 10888628032859, Natrelle Inspira SSM 210cc BI (US) 10888628032866, Natrelle Inspira SSM 240cc BI (US) 10888628032873, Natrelle Inspira SSM 255cc BI (US) 10888628032880, Natrelle Inspira SSM 275cc BI (US) 10888628032897, Natrelle Inspira SSM 295cc BI (US) 10888628032903, Natrelle Inspira SSM 310cc BI (US) 10888628032910, Natrelle Inspira SSM 330cc BI (US) 10888628032927, Natrelle Inspira SSM 345cc BI (US) 10888628032934, Natrelle Inspira SSM 360cc BI (US) 10888628032941, Natrelle Inspira SSM 375cc BI (US) 10888628032958, Natrelle Inspira SSM 405cc BI (US) 10888628032965, Natrelle Inspira SSM 445cc BI (US) 10888628032972, Natrelle Inspira SSM 485cc BI (US) 10888628032989, Natrelle Inspira SSM 520cc BI (US) 10888628032996, Natrelle Inspira SSM 560cc BI (US) 10888628033009, Natrelle Inspira SSM 600cc BI (US) 10888628033016, Natrelle Inspira SSM 640cc BI (US) 10888628033023, Natrelle Inspira SSM 685cc BI (US) 10888628033030, 7608 SSF/UDI: Natrelle Inspira SSF 180cc BI (US) 10888628033054, Natrelle Inspira SSF 200cc BI (US) 10888628033061, Natrelle Inspira SSF 220cc BI (US) 10888628033078, Natrelle Inspira SSF 240cc BI (US) 10888628033085, Natrelle Inspira SSF 265cc BI (US) 10888628033092, Natrelle Inspira SSF 295cc BI (US) 10888628033108, Natrelle Inspira SSF 325cc BI (US) 10888628033115, Natrelle Inspira SSF 335cc BI (US) 10888628033122, Natrelle Inspira SSF 345cc BI (US) 10888628033139, Natrelle Inspira SSF 365cc BI (US) 10888628033146, Natrelle Inspira SSF 385cc BI (US) 10888628033153, Natrelle Inspira SSF 415cc BI (US) 10888628033160, Natrelle Inspira SSF 450cc BI (US) 10888628033177, Natrelle Inspira SSF 485cc BI (US) 10888628033184, Natrelle Inspira SSF 520cc BI (US) 10888628033191, Natrelle Inspira SSF 560cc BI (US) 10888628033207, Natrelle Inspira SSF 605cc BI (US) 10888628033214, Natrelle Inspira SSF 650cc BI (US) 10888628033221, Natrelle Inspira SSF 695cc BI (US) 10888628033238, Natrelle Inspira SSF 745cc BI (US) 10888628033245, Natrelle Inspira SSF 770cc BI (US) 10888628033252, 7609 SSX/UDI: Natrelle Inspira SSX 200cc BI (US) 10888628033269, Natrelle Inspira SSX 225cc BI (US) 10888628033276, Natrelle Inspira SSX 255cc BI (US) 10888628033283, Natrelle Inspira SSX 285cc BI (US) 10888628033290, Natrelle Inspira SSX 310cc BI (US) 10888628033306, Natrelle Inspira SSX 340cc BI (US) 10888628033313, Natrelle Inspira SSX 375cc BI (US) 10888628033320, Natrelle Inspira SSX 400cc BI (US) 10888628033337, Natrelle Inspira SSX 420cc BI (US) 10888628033344, Natrelle Inspira SSX 445cc BI (US) 10888628033351, Natrelle Inspira SSX 470cc BI (US) 10888628033368, Natrelle Inspira SSX 495cc BI (US) 10888628033375, Natrelle Inspira SSX 525cc BI (US) 10888628033382, Natrelle Inspira SSX 545cc BI (US) 10888628033399, Natrelle Inspira SSX 560cc BI (US) 10888628033405, Natrelle Inspira SSX 580cc BI (US) 10888628033412, Natrelle Inspira SSX 615cc BI (US) 10888628033429, Natrelle Inspira SSX 650cc BI (US) 10888628033436, Natrelle Inspira SSX 700cc BI (US) 10888628033443, Natrelle Inspira SSX 750cc BI (US) 10888628033450, Natrelle Inspira SSX 800cc BI (US) 10888628033467, 7513 SRL/UDI: Natrelle Inspira SRL 110cc BI (US) 10888628006645, Natrelle Inspira SRL 125cc BI (US) 10888628006652, Natrelle Inspira SRL 140cc BI (US) 10888628006669, Natrelle Inspira SRL 170cc BI (US) 10888628006676, Natrelle Inspira SRL 200cc BI (US) 10888628006683, Natrelle Inspira SRL 230cc BI (US) 10888628006690, Natrelle Inspira SRL 260cc BI (US) 10888628006706, Natrelle Inspira SRL 290cc BI (US) 10888628006713, Natrelle Inspira SR
FDA Enforcement
Class III
·Terminated·Allergan PLC·December 25, 2019