18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESPONSE Rib and Pelvic System
FDA 510(k)
FDA Class 2
·Orthopedic
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094173·KM33-105
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM
Brasseler USA
FDA UDI
Provision·00810041064851·
Reprocessed Oscillating/Sagittal Saw Blade, Thick, 18.5 x 9 x 0.51mm
FDA UDI
SURETEK MEDICAL·B390KM331051·
Brasseler USA
FDA UDI
Provision·B504OMKM331050·
NA
FDA UDI
STERILMED, INC.·10888551016117·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
AIDI Bioperfect Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI12331051·AIDI Bioperfect® NanoMicro® 3.3mm x 10.5mm, 3.0...
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
FDA 510(k)
FDA Class 2
·Microbiology
BREEZE NEBULIZER (NBR-10X)
FDA 510(k)
FDA Class 2
·Anesthesiology
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 18, 2008
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 22, 2011
UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 18, 2013
UNKNOWN ASNIS III CANNULATED SCREW
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HWC·September 9, 2019
UNKNOWN ASNIS III CANNULATED SCREW
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HWC·September 9, 2019
UNKNOWN ASNIS III CANNULATED SCREW
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HWC·September 9, 2019
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025