20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
FDA 510(k)
FDA Class 2
·Cardiovascular
IDEAL
FDA UDI
Medos International Sàrl·10886705011681·IDEAL Suture Shuttle, Straight Crescent
Ophthlamic Speculum
FDA UDI
KATENA PRODUCTS, INC.·10841668115159·BARRAQUER SPECULUM Disposable with Finger tabs ...
IPL HAIR REMOVAL DEVICE CT05
FDA Adverse Event
Injury
·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·February 19, 2026
HAND-HELD HAIR REMOVAL DEVICE
FDA Adverse Event
Injury
·SHENZHEN CHUANGTONG YIGOU TECHNOLOGY CO., LTD.·Product code OHT·March 9, 2026
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522510070·
Squadron Lumbar Cage
FDA UDI
VALORUS SPINE LLC·00811771035579·Squadron Parallel Bullet Nose PLIF Cage, 25mm x...
Squadron Lumbar Cage
FDA UDI
VALORUS SPINE LLC·00810065990457·Squadron Anatomical Bullet Nose PLIF Cage, 25mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197059459·Endarterectomy Stripper
7mm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251007400·ceraMotion® Ti Opaque B2, 40 g / dental ceramic...
Squadron Lumbar Cage
FDA UDI
VALORUS SPINE LLC·00811771037375·Squadron Lordotic Bullet Nose PLIF Cage, 25mm x...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251007200·ceraMotion® Ti Opaque B2, 20 g / dental ceramic...
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
FDA 510(k)
FDA Class 2
·Radiology
ACCU02 SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·September 13, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 14, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2013
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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