16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rachel's Remedy
FDA 510(k)
FDA Class 1
·Physical Medicine
AGXO
FDA UDI
Oticon A/S·05707131284822·H150V2, MINIRITE 312 WL SGR AGXO
Trial Cage 25deg 18M
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066765·
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: EXPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·January 19, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2018
AMISTEM H HA COATED LAT STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·July 29, 2015
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 7, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
OT VERIO REFLECT METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·February 9, 2024
TRAC KNEE TIBIAL BEARING ARCOM UHMWPE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 30, 2018
OT VERIO REFLECT METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·February 9, 2024
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024