14 results
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18ms
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Sources: EU EUDAMED, US FDA
MICROVASIVE PULMONARY GUIDEWIRE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220593·Safco T&F bur - 12 bladed, carbide, #7406 egg F...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120220591·Carbide, flame, finishing bur
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112526·BARRON VACUUM TREPHINE 8.25MM
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575409099·Acetabulum prosthesis trial, reusable - Vario-C...
8100/8500 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AMT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 26, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·March 10, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP.·Product code NBW·March 28, 2008
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·February 19, 2025
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018