16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATEC Lateral Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
M/DN®
FDA UDI
Zimmer, Inc.·00889024039919·
M/DN®
FDA UDI
Zimmer, Inc.·00889024039926·
GUIDEZILLA GUIDE EXTENSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G7 PPS LTD ACET SHELL 54F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·November 13, 2018
ATLAS PLUS HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
ENDOPATH** DEXTRUS* SEAL CAP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 12, 2013
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HWC·February 13, 2023
LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HWC·February 13, 2023
BONE SCREW, T8 FULL THREAD, 2.7MM/L20MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HWC·February 13, 2023
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026