23 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239946·
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000516·MCK Patellofemoral Component
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555105·
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107040·TRIAL 90-SRK-180416 POLY PS 4X16MM
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197530118·RZ Tebbet Breast Retractor
180x16...
All Poly Keel Punch
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215063962·
VIDAS® TOXO IGG II
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code LGD·February 16, 2018
ABL835 FLEX ANALYZER WITH PLEURAL PH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSULATION TESTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
MCK TIBIAL ONLAY INSERT-SZ 8-8MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·March 7, 2017
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
VIDAS® HS TROPONIN I
FDA Adverse Event
Injury
·BIOMERIEUX SA·Product code MMI·October 9, 2017
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·April 16, 2019
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·July 31, 2019