Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
168073–168096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1980
IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
K800228 · DBE
Clinical Sciences, Inc.
Immunology · 16d
Cleared Feb 21, 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · DBM
Clinical Sciences, Inc.
Immunology · 16d
Cleared Feb 21, 1980
ABCO ULTRA SLIDE MICROSCOPE SLIDE
K800232 · KEW
Abco Dealers, Inc.
Pathology · 16d
Cleared Feb 21, 1980
RH-HR NEGATIVE CONTROL REAGENT
K800239 · KSF
Gotham Biologics, Inc.
Hematology · 16d
Cleared Feb 21, 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 15d
Cleared Feb 19, 1980
VISALENS ALL PURPOSE SOLUTION FOR LENS
K791523 · HPX
Pfizer, Inc.
Ophthalmic · 193d
Cleared Feb 19, 1980
ECHO-OCULOMETER #3000
K791766 · IYO
Jedmed Instrument Co.
Radiology · 162d
Cleared Feb 19, 1980
UVB LIGHT BOX - UVB LIGHT BOOTH
K792500 · FTC
Sun Shanty, Inc.
General & Plastic Surgery · 77d
Cleared Feb 19, 1980
TREADMILL MODEL 3060
K792661 · IOL
Cambridge Instruments, Inc.
Physical Medicine · 55d
Cleared Feb 19, 1980
HUESTIS FLEXI-HOLDER
K792721 · IXA
Huestis Machine Corp.
Radiology · 50d
Cleared Feb 19, 1980
FUSON BONE PLUG, RADIOPAQUE
K800142 · JDS
Zimmer, Inc.
Orthopedic · 29d
Cleared Feb 19, 1980
DYNAMIC EXTENSOR SPLINT
K800143 · ILH
Biomet, Inc.
Physical Medicine · 29d
Cleared Feb 19, 1980
FEMORAL CEMENT RESTRICTOR
K800144 · JDS
Biomet, Inc.
Orthopedic · 29d
Cleared Feb 19, 1980
SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
K800152 · KGO
Surgikos, Inc.
General Hospital · 28d
Cleared Feb 19, 1980
IMMUNOGLOBULIN A REAGENT SYSTEM
K800211 · CZP
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 19, 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · CZW
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 19, 1980
SURGITEK FOERSTER FACE LIFT BANDAGE
K800248 · FRL
Medical Engineering Corp.
General Hospital · 13d
Cleared Feb 19, 1980
SURGITEK FOERSTER MAMMARY BANDAGE
K800249 · FRL
Medical Engineering Corp.
General Hospital · 13d
Cleared Feb 19, 1980
ACUFEX FORCEPS
K800273 · HTD
Acufex Microsurgical, Inc.
General & Plastic Surgery · 12d
Cleared Feb 19, 1980
ACUFEX PROBES
K800274 · HXB
Acufex Microsurgical, Inc.
Orthopedic · 12d
Cleared Feb 19, 1980
CEBOTOME DRILL
K800275 · HSZ
American Sterilizer Co.
Orthopedic · 12d
Cleared Feb 19, 1980
ENDEX REAMERS PULP CANAL, ENDODONTIC
K800291 · EKP
Ipco Corp.
Dental · 8d
Cleared Feb 19, 1980
ENDEX BROACH, ENDODONTIC
K800292 · EKW
Ipco Corp.
Dental · 8d
Cleared Feb 19, 1980
FILE, PULP CANAL
K800293 · EKS
Ipco Corp.
Dental · 8d