21 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
FDA 510(k)
FDA Class 2
·Neurology
HAGER ZOOM MAGNIFIERS +1.0
FDA UDI
HAGER WORLDWIDE, INC.·D2481009121·Protective Eyewear
Copper Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989027365·COPPER NITI 27 BAF 16X22U/L PK10
FEATHER WEIGHT BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921009120·FEATHER WEIGHT BULLDOG CLAMP STRAIGHT JAW
Mariner MIS
FDA UDI
Seaspine Orthopedics Corporation·10889981293468·Bevel Stylet, Standard
Arena-L®
FDA UDI
SPINEFRONTIER, INC.·00190361005896·Arena-L, 35x26, Lordotic 8 degrees, 12H
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981321208·Shoreline Flex Drill, 12mm
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857527942·AN Lordotic Spreader Size 8.5x28x5 mm, 18°
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613327102161·Posterior Stabilized Tibial Insert
Genius Tibial Trial Monobloc PS - 12mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215072391·
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A
FDA 510(k)
FDA Class 2
·Orthopedic
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
EPD 60000 RPM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 19, 2014
UNKNOWN
FDA Adverse Event
Injury
·UNKNOWN·Product code KNT·May 19, 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
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025