21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
PIN SCREW
FDA UDI
BK MEDITECH CO.,LTD.·08809155854979·Wire Pin Screw, 2.3mm Shaft Diameter x 2.3mm Th...
PIN SCREW
FDA UDI
BK MEDITECH CO.,LTD.·08809155854917·Wire Pin Screw, 2.3mm Shaft Diameter x 2.3mm Th...
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
STAXX XDL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G7 OSSEOTI ACETABULAR SHELL 3 HOLE 50MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 2, 2025
G7 DUAL MOBILITY ACETABULAR SYSTEM LINER 40MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 2, 2025
ACTIVE ARTICULATION HIP SYSTEM E1 HIP BRG 28X40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 2, 2025
INTERCHANGEABLE ULNAR ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·June 27, 2013
INTERCHANGEABLE HUMERAL ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026