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Data / Medical devices / United States / RG Medical USA

RG Medical USA: FDA-registered device maker in Mount Juliet, TN, United States, 13 510(k) clearances

RG Medical USA is registered with the FDA (registration 1057358) in Mount Juliet, TN, United States. It lists 25 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 25, 2008. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch RG Medical USA
FDA registration number
1057358
FEI number
1000208608
Address
630A Pleasant Grove Rd., Mount Juliet, TN, United States, 37122
Owner or operator
RG Medical USA (9007726)
Roles
Repackager or relabeler, Specification developer
First device listed
November 15, 2006
Registered through
2026
Brand names listed
RG Medical

Devices it lists

DeviceProduct codeClassRoleSource
Camera, Television, Endoscopic, Without AudioFWF1Repackager or relabeleraccessdata.fda.gov
Cannula, Trocar, OphthalmicNGY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrosurgical DeviceDWG2Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeler, Specification developeraccessdata.fda.gov
Filter, Infusion LineFPB2Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Repackager or relabeler, Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeler, Specification developeraccessdata.fda.gov
Led Light SourceNTN2Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Repackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeler, Specification developeraccessdata.fda.gov
ResectoscopeFJL2Repackager or relabeler, Specification developeraccessdata.fda.gov
Resectoscope, Working ElementFDC2Repackager or relabeler, Specification developeraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Repackager or relabeleraccessdata.fda.gov
Tray, Irrigation, SterileEYN2Repackager or relabeler, Specification developeraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Repackager or relabeleraccessdata.fda.gov
Warmer, Infant RadiantFMT2Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 25, 2008K072753REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIESHIFSubstantially EquivalentRg Medical USAaccessdata.fda.gov
October 16, 2003K030857MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIESEOBSubstantially EquivalentMahe Intl., Inc.accessdata.fda.gov
August 5, 1999K991426MAHE INSTRUMENTSFDCSubstantially EquivalentMahe Intl., Inc.accessdata.fda.gov
May 21, 1998K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPSHETSubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
December 5, 1994K942823MAHE INSTRUMENTSDWGSubstantially EquivalentMahe Intl., Inc.accessdata.fda.gov
November 2, 1994K942821MAHE INSTRUMENTSGEISubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
August 23, 1994K942819TROCAR WITH SHIELDGCJSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
June 27, 1994K933768COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIESHETSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
May 26, 1994K933767FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSYHFBSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
March 23, 1994K933770FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPELRCSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
March 14, 1994K935442MAHE INSTRUMENTSGCJSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
February 1, 1994K933772PUNCH SURGICALLXHSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov
July 22, 1993K925624MICROSURGICAL INSTRUMENTSGCJSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov

Compare with other makers

Updated January 25, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.