35 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPONDY SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Alpen Carbides
FDA UDI
Dent4You AG·07630392905954·Alpen Carbides 956-FG-0.90, 10 pcs
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964066764·Endo Carry-On Procedure Kit
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989027570·COPPER NITI 40 BAF 21X25UPLG PK10
BETA TITANIUM ARCHWIRE
FDA UDI
Ortho Organizers, Inc.·00190707067229·.018 X .018 Lower Pro Form™ Beta Titanium Archw...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450196823·
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479241718·Therapy Putty xx-soft resistance level 2 oz
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
FDA 510(k)
FDA Class 2
·Cardiovascular
GYNECARE TVT-ABBREVO MINI LCM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 30, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 24, 2011
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·January 18, 2016
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013
5.5MM TI CURVED ROD 45MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015