26 results
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27ms
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Sources: EU EUDAMED, US FDA
WHOOP, Inc.
Manufacturer
🇺🇸 United States
Whoop, Inc.
FDA registration
Whoop, Inc.·1 product·🇺🇸 United States
WHOOP ECG Feature
FDA UDI
Whoop, Inc.·00860012964819·
WHOOP 4.0
FDA Adverse Event
Injury
·WHOOP, INC.·Product code QDA·October 20, 2025
WHOOP BAND
FDA Adverse Event
Injury
·WHOOP INC.·Product code QDA·February 24, 2026
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
SURGICEL ABSORBABLE HEMOSTAT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code LMG·June 15, 2005
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 17, 2015
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 17, 2015
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·January 9, 2006
ULTRAPRO HERNIA SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 13, 2014
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 11, 2012
VICRYL PLUS POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 7, 2015
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459258(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459265(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·April 8, 2020
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 11, 2013
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459227(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459234(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·April 8, 2020
MESH, SURGICAL, POLYMERIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 15, 2011
SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GDW·March 11, 2015
GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·March 4, 2015
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LNQ·July 2, 2019