27 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
FDA 510(k)
FDA Class 2
·General Hospital
Redicare
FDA UDI
REDICARE LLC·B70901020730·First Aid Kit intended for workplace injuries, ...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM
SYMPHONY
FDA UDI
Medos International Sàrl·10705034523491·SYMPHONY OCT SYSTEM ADJUSTABLE ROD TITANIUM ALL...
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020730·SPIRA®-A Integrated,Trial, 28x38mm, 30° Lordoti...
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020730·Trial 30x38mm, 8° Lordotic, 9mm
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1020730·Trial, 12 x 14.5mm, 3° Lordotic, 5mm
SYMPHONY
FDA UDI
Medos International Sàrl·10705034515786·SYMPHONY OCT SYSTEM ADJUSTABLE ROD TITANIUM ALL...
PAIN CARE 3000
FDA 510(k)
FDA Class 2
·General Hospital
OLYMPUS SPRAY CATHETER PW-6C-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 19, 2024
BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 4, 2021
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·April 22, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·September 19, 2014
FOUNDATION KNEE INSTRUMENT
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code LXH·April 14, 2011
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Model Number L210 PROPONENT SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021