14 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869642453·MOSS Ti Pedicle Screw, Ø10.0x85mm DL, polyaxial...
Sochi
FDA UDI
Altus Spine, LLC·00843210173672·Pre-Curved Rod, 3.5mm x 85mm
SPINESMITH CYNCH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDFUSION 3500 PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·January 4, 2023
TAPERLOC 133 MP TYPE1 PPS HO 16.0 M T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·January 10, 2020
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·September 16, 2020
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 20, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 22, 2011
VP2000
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR·Product code KEY·September 29, 2008
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 20, 2022
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018