20 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PADLOCK CLIP-12
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743731·ACHIMED ACHILLES SUPP SAND IV
Unity Total Knee System
FDA UDI
CORIN LTD·05056139249181·UNITY KNEE™ PS-C INSERT - Size 8 x 14mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720363·Graefe Eye Dressing Forceps 2-3/4" (7cm), strai...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521208140·
TALOS®-C
FDA UDI
SpineArt SA·07640375236494·STERILE TALOS®-C (HA) PEEK PLANAR IBFD
AMBIT TUNNELER
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECYSYS SHBG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
VNGRD CR TIB BRNG 63/67X12
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 20, 2013
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·September 26, 2014
SYNCHRON LX 20 CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 10, 2011
2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 1, 2015
BD SYRINGE W/ BD LUER-LOK TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 10, 2019
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026