Data / Medical devices / United States / Gemstar, Inc.
Gemstar, Inc.: FDA-registered device maker in Monsey, NY, United States, 15 510(k) clearances
Gemstar, Inc. is registered with the FDA (registration 2434982) in Monsey, NY, United States. It lists 14 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 1, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2434982
- Address
- 27 Robert Pitt DR., Monsey, NY, United States, 10952
- Owner or operator
- GEMSTAR, INC. (2434982)
- Roles
- Repackager or relabeler
- First device listed
- September 14, 2017
- Registered through
- 2027
- Brand names listed
- Electrode, OTOSCOPE
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 1, 2015 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| September 8, 2010 | K101249 | STERIGAGE MODEL 1243RA, 1243RB, 1243RE | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| December 4, 2009 | K093199 | 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK | JOJ | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 29, 2009 | K090569 | MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 9, 2009 | K082478 | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 | BZG | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 6, 2001 | K012539 | VERASTEP | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| February 5, 1996 | K955103 | 3M NO STING BARRIER FILM | KMF | Substantially Equivalent | 3M Medical Products Group | accessdata.fda.gov |
| April 6, 1995 | K950787 | WELCH ALLYN OTOSCOPE | ERA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 2, 1994 | K941272 | KLEENSPEC | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 30, 1994 | K941943 | SURGICAL ADHESIVE TAPE | KGX | Substantially Equivalent | Raleigh Lions Clinic For the Blind, Inc. | accessdata.fda.gov |
| December 13, 1989 | K896155 | RED DOT CARDIAC SENSOR SYSTEM | DRX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| November 3, 1989 | K896171 | EYE PATCH | HOY | Substantially Equivalent | Eye Garter Company, Inc. | accessdata.fda.gov |
| July 14, 1982 | K821909 | LITTMAN TUNABLE STETHOSCOPE 2136 | LDE | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| February 21, 1978 | K780231 | BANDAGE, ELASTIC | FQM | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Bandage, Elastic
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Otoscope
- All makers of Dressing, Wound, Hydrophilic
- All makers of Indicator, Biological Sterilization Process
Updated December 1, 2015. 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.