15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POLYPLEX STIMULATING CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70601861·Mini-Mono-Brackets Roth 'N' .018" 100 Brackets ...
SAFE-T-FILL®
FDA UDI
Ram Scientific, Inc·10643351000274·SAFE-T-FILL Plastic Blood Gas Capillary Tubes, ...
SELOX SR 53
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·September 1, 2006
SELOX SR 45
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·September 1, 2006
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EU PPICC SOLO, 4 FR S/L
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·April 11, 2013
STEREOSTACTIC PROBE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code HAW·May 19, 2008
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 15, 2011
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
TENACULUM FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 9, 2013
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012