16 results · 18ms · Sources: EU EUDAMED, US FDA

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ENTERAL & NASOGASTRIC SOL. ADMIN. SET

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526785045·EPICOMED ELB SUPPORT SAND V

DSQ Alert™ HT HAV Primer Mix ASR

FDA UDI
Elitechgroup Mdx LLC·03661540952883·Product Description DSQ Alert® HT HAV Primer Mi...

STABILIZER TIPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896070240·HEARTLINE STABILIZER TIPS

STABILIZER TIPS

FDA UDI
SONTEC INSTRUMENTS, INC.·B09928008150·HEARTLINE STABILIZER TIPS

SCANLAN® Jacobson Micro Scissors

FDA UDI
SCANLAN INTERNATIONAL INC·00846159010855·Thompson Valve Scissors

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835872·Single Port, 3mm x 10cm, Aluminum Handle

AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)

FDA 510(k)
FDA Class 2 ·Cardiovascular

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SENSOR

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZO·May 8, 2014

WAVELIGHT FS200 FEMTOSECOND LASER

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code GEX·October 17, 2012

UNK DEPUY CEMENT

FDA Adverse Event
Injury ·DEPUY CMW·Product code LOD·August 10, 2010

95 DEG DCS® PLATE 12 HOLES/210MM-STERILE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code KTT·November 20, 2014

VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

FDA Recall
Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·March 12, 2020

Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).

FDA Recall
Terminated ·Pelstar, Llc·Product code FRI·October 7, 2011

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022