11 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Ideal pedicle screw spinal system

FDA 510(k)
FDA Class 2 ·Orthopedic

MAT PLATFORM,1100LB,GRAY,5X7',20-30"

FDA UDI
Hausmann Enterprises, LLC·00840314801128·

MAT PLATFORM,1100LB,BLACK,5X7,20-30"

FDA UDI
Hausmann Enterprises, LLC·00840314801142·

MAT PLATFORM,1100LB,GREEN,5X7,20-30"

FDA UDI
Hausmann Enterprises, LLC·00840314801135·

MAT PLATFORM,1100LB,BLUE,5X7',20-30"

FDA UDI
Hausmann Enterprises, LLC·00840314801111·

DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CUTTING EDGE SPINE INTERBODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

INFINITY DENTAL IMPLANT SYSTEM

FDA Adverse Event
Injury ·ACE SURGICAL SUPPLY CO.·Product code DZE·May 30, 2013

PLMA DVC V11.51 1 N

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 12, 2014

ASR 300 SPIKED CUP SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·June 23, 2011

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