11 results · 18ms · Sources: EU EUDAMED, US FDA

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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