14 results · 19ms · Sources: EU EUDAMED, US FDA

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DIAGNOSTIC PRODUCTS CORP. RIA CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526785021·EPICOMED ELB SUPPORT SAND III

DSQ Alert® HT JCV Primer Mix ASR

FDA UDI
Elitechgroup Mdx LLC·03661540952821·DSQ Alert® HT JCV Primer Mix is an analyte spec...

Heartline Stabilizer Arm

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896114432·Heartline Stabilizer Arm Deluxe With Swivel Body

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835858·Basket Cannula, 3.7mm x 30cm, Aluminum Handle

ADP,8,P800,S800,1/4" N,RAULAND & DUKAN

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828118699·ADP,8,P800,S800,1/4" N,RAULAND & DUKAN

PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

GUARDIAN REAL-TIME MONITIOR

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

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 17, 2012

AGILITY TIBIAL INSERT SZ 4

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSN·August 10, 2010

REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTD·July 15, 2019

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

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