19 results · 21ms · Sources: EU EUDAMED, US FDA

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150 DRIVER/REAMER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Elite Orthopaedics

FDA UDI
Elite Orthopaedics, Inc.·00816591013387·Post Op Telescoping Knee Brace

ACUMED

FDA UDI
Acumed LLC·10806378041105·Univ Tray Assy Olec Threaded Compr Rod

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306810046·Khouri Reinjector, 14G x 25cm, Curved, Luer

Falcon

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730088543·Mini Three Jaw Pliers

My Medical

FDA UDI
My Medical Store LLC·G4258003120·Mercedes Cannula 14G x 25 cm Curved 800-312

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197418973·Rectal Blade, large 23x98mm

ADARA

FDA UDI
HNM TOTAL RECON LLC·00841742103051·ADARA ø4.5mm Cortical Screw, Full Thread, Self-...

iNSitu™ Hip System

FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127028793·Blade Femoral Broach Size 12

VARELISA SM ANTIBODIES

FDA 510(k)
FDA Class 2 ·Immunology

DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
STRYKER CORPORATION·07613252026723·Payner 360 Tip, Universal

GIA UNIVERSAL

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·May 2, 2014

CAREASSIST BED

FDA Adverse Event
Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·October 9, 2012

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·May 27, 2015

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

FDA Enforcement
Class II ·Terminated·Philips Healthcare Inc.·September 26, 2012

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022