19 results
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18ms
·
Sources: EU EUDAMED, US FDA
450 DRILL/800 DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003111·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003110051·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003110101·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003111001·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127028786·Blade Femoral Broach Size 11
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418966·Rectal Blade, small
22x72mm
Stryker
FDA UDI
Provision·B504OM54508003110·
SUPERION INDIRECT DECOMPRESSION SYSTEM
FDA Adverse Event
Injury
·VERTIFLEX INC.·Product code NQO·November 12, 2020
PARAPOST FIBER WHITE
FDA 510(k)
FDA Class 1
·Dental
MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·May 2, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007
MOBILE LINER ØINT 28 MM Ø40 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·October 21, 2022
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 20, 2016
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code LFL·March 22, 2016
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
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