1,366 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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D R Burton OxyPAP
FDA 510(k)
FDA Class 2
·Anesthesiology
HIGH CONCENTRATION NON-REBREATHING PAEDIATRIC OXYGEN MASK
FDA UDI
Intersurgical Incorporated·05030267051779·HIGH CONCENTRATION NON-REBREATHING PAEDIATRIC O...
QUADRALITE, ANAESTHETIC FACE MASK, SIZE 2, SMALL ADULT, WHITE SEAL, 22F
FDA UDI
Intersurgical Incorporated·05030267078912·QUADRALITE, ANAESTHETIC FACE MASK, SIZE 2, SMAL...
PERCUTANEOUS COMPRESSION PLATE (PC.C.P)
FDA UDI
ORTHOFIX SRL·18032568865837·GOTFRIED PC.C.P. BUTTERFLY SCREW
Midmark
FDA UDI
MIDMARK CORPORATION·00841709122187·LED Dental Light Head and Flex Arm Assembly use...
Patriot SI
FDA UDI
Spinal Simplicity, LLC·M9432001920000·Bone Graft Plunger
LEONE SPA
FDA UDI
LEONE SPA·08033707069584·D.B. BRACKET REMOVING PLIERS
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101056·KNAPP RETRACTOR 4-PRONG BLUNT
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IMAGYS
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
STRYKER CORPORATION·04546540042293·2108 Series Sagittal Rasp (20.1 x 46.0mm)
Horizon 24 Flex Centrifuge, Westpac
FDA UDI
DRUCKER DIAGNOSTICS·00810052860701·General purpose laboratory centrifuge for sampl...
NA
FDA UDI
Exactech, Inc.·10885862523617·CR FEMORAL PEG DRILL
642E Centrifuge, Westpac Labs
FDA UDI
DRUCKER DIAGNOSTICS·00810052861302·General purpose laboratory centrifuge for sampl...
Horizon 6 Centrifuge, WestPac
FDA UDI
DRUCKER DIAGNOSTICS·00810052860329·General purpose laboratory centrifuge for sampl...
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Diagnostics Scarborough, Inc.·April 23, 2025
TECHSTAR XL 6F
FDA Adverse Event
Injury
·PERCLOSE, INC.·Product code MGB·March 29, 2000
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 4, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 27, 2013