20 results
·
24ms
·
Sources: EU EUDAMED, US FDA
TULA Iontophoresis System with Earset
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III
Oticon
FDA UDI
Oticon A/S·05707131288981·H11V2 TI, RITE 312 WL TC
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239746·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE
Genius-A Instrument Case 4 Patella
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074272·
RELIANCE ENDOSCOPE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 23, 2016
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·July 21, 2010
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·July 21, 2010
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·July 21, 2010
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·July 21, 2010
OSS POROUS IM STEM 18.5 X 225
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 17, 2017
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 6, 2013
SYNCHRON LX20 PRO SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·June 8, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 5, 2008
OSS SEGMENTAL ELLIPTICAL FEMORAL 7 CM RIGHT POROUS COATED
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 6, 2017
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016