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
164689–164712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1981
COAT-A-COUNT CORTISOL RIA KIT
K810891 · CGR
Diagnostic Products Corp.
Chemistry · 12d
Cleared Apr 14, 1981
INSULATIVE COATING FOR CARD. PULSE GEN
K810901 · DXY
Intermedics, Inc.
Cardiovascular · 11d
Cleared Apr 14, 1981
NEWBORN BOVINE SERUM
K810903 · KIS
Biolabs, Inc.
Pathology · 11d
Cleared Apr 14, 1981
BOVINE CALF SERUM
K810904 · KIS
Biolabs, Inc.
Pathology · 11d
Cleared Apr 14, 1981
ISOMUNE-CK
K810905 · JHW
Hoffmann-La Roche, Inc.
Chemistry · 11d
Cleared Apr 14, 1981
TRI-LEVEL NDI CONTROL
K810906 · JJY
Nuclear Diagnostics, Inc.
Chemistry · 11d
Cleared Apr 14, 1981
KOVA TROL I HUMAN URINE (DRIED)
K810917 · JJW
Icl Scientific
Chemistry · 8d
Cleared Apr 14, 1981
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K810927 · CCK
Allied Healthcare Products, Inc.
Anesthesiology · 8d
Cleared Apr 14, 1981
PERFRINGENS AGAR BASE
K810929 · JSI
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 14, 1981
SS AGAR (MODIFIED)
K810931 · JSI
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 14, 1981
VITOX
K810932 · JSK
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 14, 1981
VOTEL-JOHNSON AGAR (MODIFIED)
K810933 · JSI
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 11, 1981
SINGLE USE SELDINGER/COURNAND PERC. NDL
K810859 · DRE
Procedure Products, Inc.
Cardiovascular · 12d
Cleared Apr 10, 1981
DOPSCAN MODEL 1050
K810561 · DPW
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Apr 10, 1981
SYNCHRONIZER #208
K810588 · IXO
Brattle Instrument Corp.
Radiology · 37d
Cleared Apr 10, 1981
NEURO-ECAT
K810589 · KPS
Eg&G Ortec, Inc.
Radiology · 37d
Cleared Apr 10, 1981
P.R.M. 80
K810590 · IZW
T.E.M. Instruments , Ltd.
Radiology · 37d
Cleared Apr 10, 1981
X-RAY COLLIMATING DEVICES
K810598 · IZW
Midmark Corp.
Radiology · 35d
Cleared Apr 10, 1981
PHARMALOG
K810698 · DSH
Circadian, Inc.
Cardiovascular · 25d
Cleared Apr 10, 1981
CHROMOPS FM-100 COLOR VISION TESTER
K810700 · HIT
Visidyne Corp.
Ophthalmic · 25d
Cleared Apr 10, 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751 · BZC
General Electric Co.
Anesthesiology · 21d
Cleared Apr 10, 1981
SKIN STAPLE REMOVER
K810785 · KDC
Rowley Mfg. Co.
General & Plastic Surgery · 18d
Cleared Apr 10, 1981
THERMOMETER, ELECTRONIC CLINICAL
K810814 · FLL
Her-Mar, Inc.
General Hospital · 17d
Cleared Apr 10, 1981
NON-INVASIVE AMPLIFIER
K810828 · DRR
Henry Ford Hospital
Cardiovascular · 17d