15 results
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18ms
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Sources: EU EUDAMED, US FDA
Invia Ease Negative Pressure Wound Therapy (NPWT) System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2141120·VITA TITANKERAMIK GINGIVA, G1, 12 g
NA
FDA UDI
Medos International Sàrl·10886705003532·THREADED CLEAR CANNULA WITH OBTURATOR 7mm x 110mm
ESR-Chex
FDA UDI
STRECK, INC.·00844509001652·A two-level hematology control used to monitor ...
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114451·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 S...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167742141120·
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857522367·Trial Size 13x16x9 mm, 15°
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640270066660·CERVICAL VARIABLE SELF TAPPING SCREW (x2) Ø4.1 L12
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1742141120·
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
FDA 510(k)
FDA Class 1
·General Hospital
XChange Device, XChange System
FDA 510(k)
FDA Class 2
·Anesthesiology
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION STANDARD LOCKING BOLT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HTN·October 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011
QUILL KNOTLESS ISSUE CLOSUR DEVICE
FDA Adverse Event
Other
·SURGICAL SPECIALITIES PUERTO RICO INC. DBA ANGIOTECH·Product code NEW·July 3, 2013
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017