28 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BIOROOT RCS
FDA 510(k)
FDA Class 2
·Dental
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975052797·
LINK Instruments - Impactors, extractors and insertion
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575032945·Orthopaedic implant inserter/extractor, reusabl...
ALEUTIAN Interbody Systems
FDA UDI
VB Spine LLC·10888857560703·Disc Spreader Size 6 mm
Portex
FDA UDI
ICU MEDICAL, INC.·15019517083910·
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 18, 2023
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder
FDA UDI
VASOMEDICAL, INC.·00817980020184·12 CH ECG Holter ULTRA Recorder
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 27, 2023
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494695·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494688·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494701·
BOOMERANG PEEK FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011
Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient Cable
FDA UDI
VASOMEDICAL, INC.·00817980020436·Model 1306 12 CH Recorder - 10 Lead Patient Cable
PFNA BLADE PERF L75 SST
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 6, 2015
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·October 15, 2014
DERMATOME BLADES
FDA Adverse Event
Injury
·ZIMMER SURGICAL, INC.·Product code GFD·October 10, 2023