11 results
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18ms
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Sources: EU EUDAMED, US FDA
TRIPLE SUGAR IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
ERA® Micro Overdenture Attachment
FDA UDI
STERNGOLD DENTAL LLC·00841549100864·Extracoronal semi-precision attachment. Kit con...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848110440·BioMesh® 3MC - 180 x 180 mm
AURADONICS
FDA UDI
AURADONICS INC.·00810033835452·LATEX ELASTICS 1/4" 4.5 oz. - NEON, 10000 ea., ...
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
FDA 510(k)
FDA Class 2
·Orthopedic
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·March 24, 2014
KAPPA 900 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 31, 2012
PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 10, 2010
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill
FDA Recall
Open, Classified
·Certified Safety Mfg Inc·Product code LRR·April 5, 2022
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill
FDA Enforcement
Class II
·Ongoing·Certified Safety Mfg Inc·May 18, 2022