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