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
170545–170568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1979
MEDTRONIC TEMPTRON
K790261 · DTB
Medtronic Vascular
Cardiovascular · 21d
Cleared Feb 27, 1979
HEARING AID MODEL 8143
K790270 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 27, 1979
RECORDER, MEDILOG II
K790286 · DSH
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
STORAGE, DIGITAL DSC-1, CONTROL UNIT
K790288 · DXG
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
PB-4 REPLAY UNIT
K790289 · DSH
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
PREAMPLIFIER MODULE, EKG RESPIRATION
K790304 · BZQ
Abbott Medical Electronics Co.
Anesthesiology · 14d
Cleared Feb 27, 1979
HYCEL M
K790335 · JJF
Hycel, Inc.
Chemistry · 6d
Cleared Feb 26, 1979
EKG, SWITCHING BLADE AND PENS
K781799 · GEI
Bionex, Inc.
General & Plastic Surgery · 126d
Cleared Feb 26, 1979
ELECTROSURGERY MODEL 771
K781949 · GEI
Birtcher Corp.
General & Plastic Surgery · 97d
Cleared Feb 26, 1979
SERACON-N
K782039 · JIX
Bhp Diagnostix, Inc.
Chemistry · 82d
Cleared Feb 26, 1979
DEBUTRON
K782119 · KCX
Martin Electric Co.
General & Plastic Surgery · 61d
Cleared Feb 26, 1979
IEC CENTRA-7 CENTRIFUGE MODEL 2362
K782124 · JQC
Damon Corp.
Chemistry · 61d
Cleared Feb 26, 1979
PLETHYSMOGRAPH, STRAIN GAUGE
K782132 · JOM
Medasonics, Inc.
Cardiovascular · 61d
Cleared Feb 26, 1979
IMPRESSION TRAY, MDDS CUSTOM
K782153 · EBH
Chayet and Sonnenrich, P.C.
Dental · 62d
Cleared Feb 26, 1979
I TESTOTERONE
K790007 · CDZ
Cambridge Nuclear Corp.
Immunology · 55d
Cleared Feb 26, 1979
I ESTRIOL
K790008 · CGI
Cambridge Nuclear Corp.
Immunology · 55d
Cleared Feb 26, 1979
SERUM, GLUTAMIC-OXALOACETIC
K790017 · CIT
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Feb 26, 1979
SERUM, URIC ACID DETERMINATION
K790019 · CDH
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Feb 26, 1979
FLUID, RHEMOX W LYSING
K790029 · GGK
Sysmex Corp.
Hematology · 54d
Cleared Feb 26, 1979
CARDIAC OUTPUT COMPUTER, MDEL 9520A
K790047 · DXG
Edwards Laboratories
Cardiovascular · 52d
Cleared Feb 26, 1979
SURGICAL RULER AND PEN
K790084 · FZZ
Devon Industries, Inc.
General & Plastic Surgery · 41d
Cleared Feb 26, 1979
DETERMINATION OF ANTITHROMBIN III, 885
K790090 · JBQ
Sigma Chemical Co.
Hematology · 41d
Cleared Feb 26, 1979
SALIVAN PARAEIGHT TOUGHNESS
K790096 · EJS
Den-Mat Corp.
Dental · 41d
Cleared Feb 26, 1979
SALIVAN & SALIVAN BROWN
K790097 · EJS
Den-Mat Corp.
Dental · 41d