20 results · 24ms · Sources: EU EUDAMED, US FDA

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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