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
160921–160944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1982
MUELLER HINTON MED. W/5% SHEEP BLOOD
K821429 · JTZ
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MUELLER HINTON MEDIUM
K821430 · JTZ
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
XLD AGAR
K821431 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MR 600 MICROPLATE READER
K821439 · JJQ
Dynatech Corp.
Chemistry · 19d
Cleared Jun 01, 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441 · CHH
Emd Chemicals, Inc.
Chemistry · 19d
Cleared Jun 01, 1982
HEMACOUNT WRIGHTS STAIN PACK II #55952
K821457 · IAF
Accra Laboratories, Inc.
Hematology · 15d
Cleared Jun 01, 1982
ULTRAZYME PLUS CK-I, #64978,65027&65028
K821460 · CGS
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRACHEM T-BILI, #64971
K821462 · CIG
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRAZYME PLUS LDH, #64950,65038&65039
K821466 · CFJ
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRAZYME PLUS GOT, #64953,65033&65034
K821467 · CIT
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
LITTMAN OXGAL AGAR
K821493 · JSJ
Granite Diagnostics, Inc.
Microbiology · 14d
Cleared Jun 01, 1982
VERSACHEM ANALYZER
K821561 · JJQ
Emd Chemicals, Inc.
Chemistry · 7d
Cleared May 28, 1982
WORLD'S BEST (CONTRACEPTIVE)
K820564 · HIS
Rosen Kilde Stenhoj
Obstetrics & Gynecology · 87d
Cleared May 28, 1982
DISPOSABLE MULTIPLE LIGATING CLIP
K820837 · GDO
Ethicon, Inc.
General & Plastic Surgery · 63d
Cleared May 28, 1982
H-H ALIMENTATION CATHETERS
K821012 · LFJ
Holter-Hausner Intl.
Gastroenterology & Urology · 46d
Cleared May 28, 1982
CORATOMIC MODEL OVALITH 920BP
K821014 · DXY
Coratomic, Inc.
Cardiovascular · 46d
Cleared May 28, 1982
CORATOMIC MODEL OVALITH-920
K821033 · DXY
Coratomic, Inc.
Cardiovascular · 45d
Cleared May 28, 1982
OHIO ABSORBER
K821144 · BSF
Ohio Medical Products
Anesthesiology · 37d
Cleared May 28, 1982
SERIES 4 LIQUID CHROMATOGRAPH
K821219 · LDM
The Perkin-Elmer Corp.
Toxicology · 31d
Cleared May 28, 1982
SOFTIC 49
K821230 · EBI
The Healthcare Group Laboratories, Inc.
Dental · 31d
Cleared May 28, 1982
CC-700 SEVEN PARAMETER, AUTOMATED HEMAA
K821238 · GKL
Dysmex
Hematology · 30d
Cleared May 28, 1982
ROCHESTER PEAN FORCEPS
K821248 · GEN
Conphar, Inc.
General & Plastic Surgery · 25d
Cleared May 28, 1982
MAYO SCISSOR STRAIGHT 6 3/4
K821273 · EGM
Conphar, Inc.
Dental · 25d
Cleared May 28, 1982
MAYO SCISSOR STRAIGHT 5 1/2
K821275 · EGN
Conphar, Inc.
Dental · 25d