19 results
·
30ms
·
Sources: EU EUDAMED, US FDA
SureClip
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZEUS-O
FDA UDI
SPINAL ELEMENTS·00840916122515·Zeus-O Implant, 15 x 9 x 36mm
HHM
FDA UDI
Oticon A/S·05707131283092·H110V2, MINIBTE 312 WL 85 SGR HHM
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869607797·TELIX K Ti Cage 9x36mm 5°
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541930·Ferreira Style Breast Retractor
150x36...
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GYNECARE TVT-ABBREVO MINI LCM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 30, 2021
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 6, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
NESTER PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
STAINLESS STEEL EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·August 24, 2017
ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015