22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SECURE-LOCK
FDA 510(k)
FDA Class 2
·Orthopedic
Zavation
FDA UDI
Zavation LLC·00842166133068·Ti3Z CIF 14mmx16mmx6mm -9 deg
HUMERIS 135
FDA UDI
FX SOLUTIONS·03701037318560·HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY PE/TA...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318041·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY...
DeBakey Extra-Fine Multi-Purpose Clamp 60° 20mm 14.5cm straight shanks
FDA UDI
Geister Medizintechnik GmbH·04057034058213·DeBakey Extra-Fine Multi-Purpose Clamp
60° 20...
MINICONE Implant
FDA 510(k)
FDA Class 2
·Dental
ZIMMER TRABECULAR METAL TOTAL ANKLE
FDA 510(k)
FDA Class 2
·Orthopedic
COVEREDGE? 32
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2025
TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018
TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018
JOHNSON & JOHNSON
FDA Adverse Event
Malfunction
·Product code LPL·October 31, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·July 11, 2013
TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
FDA Enforcement
Class I
·Ongoing·Kirwan Surgical Products, LLC·December 25, 2024
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018