53 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
FDA Enforcement
Class II
·Terminated·Specialty Appliance Works, Inc.·April 29, 2015
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Enforcement
Class II
·Terminated·Specialty Appliance Works, Inc.·April 29, 2015
TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021
Maximum Pelvic Trainer (MPT)
FDA Recall
Terminated
·Ralston Group·Product code HIR·July 12, 2019
Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604
FDA Recall
Terminated
·Dentsply Worldwide Headqrt·Product code ELR·March 20, 2009
Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code HLF·May 19, 2010
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.
FDA Recall
Terminated
·Coltene Whaledent Inc·Product code ELR·August 21, 2018
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Recall
Terminated
·STEP-HAR MEDICAL LLC·Product code FRN·February 26, 2021
Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N REFURBISHED, Part Number CS78651
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (INTL) M, CS08654
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20 (INTL) N, Part Number CS08652
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·July 31, 2018