88 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SEASPINE SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSE BONE GRAFT 12 MG
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·May 1, 2014
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814695·GENUMEDI SILVER SIZE VI
Knob
FDA UDI
ADLER ORTHO SPA·08050507132607·KNOB FOR MALLEOLAR ROD TIBIAL CUT
ALL SILICONE FOLEY BALLOON CATHETER
FDA UDI
Sewoon Medical Co., Ltd.·08806369402620·2way/Translucent 30cc 26fr
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746108501·DB BRACKET MINI MS MAX LEFT CUSPID 022 TQ=+8 A=...
TRIDENT ALL POLY CUP
FDA 510(k)
FDA Class 2
·Orthopedic
CAPIOX ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
TRABECULAR METAL SHELL WITH CLUSTER HOLES
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWZ·May 3, 2013
ENDOVIVE STANDARD PEG KITS PULL METHOD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·August 7, 2008
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 18, 2011
BIPAP A40
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·March 4, 2026
BIPAP A40
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·March 20, 2026
TEOSYAL RHA 4
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·March 5, 2021
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy
FDA Enforcement
Class II
·Ongoing·ConMed Corporation·June 24, 2026
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
FDA Enforcement
Class II
·Ongoing·ConMed Corporation·June 24, 2026
ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
FDA Enforcement
Class II
·Ongoing·ConMed Corporation·June 24, 2026
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
FDA Enforcement
Class II
·Ongoing·ConMed Corporation·June 24, 2026
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
FDA Enforcement
Class II
·Ongoing·ConMed Corporation·June 24, 2026