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
162889–162912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1981
TEMPORARY PERVENOUS J-ATRIAL LEAD
K812781 · LDF
Cordis Corp.
Cardiovascular · 24d
Cleared Oct 29, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790 · DXY
Telectronics, Inc.
Cardiovascular · 24d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815 · DTB
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816 · DTB
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
CLEAR-RITE II
K812846 · KEM
Richard-Allan Medical Ind., Inc.
Hematology · 20d
Cleared Oct 29, 1981
XYLENE
K812847 · KEM
Richard-Allan Medical Ind., Inc.
Hematology · 20d
Cleared Oct 29, 1981
IMPROVED PLAYTEX TAMPON
K812870 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 15d
Cleared Oct 28, 1981
ELUAID
K812002 · GGK
Ortho Diagnostic Systems, Inc.
Hematology · 106d
Cleared Oct 28, 1981
MOXALACTAM 30 MCG. SENSITIVITY DISCS
K812228 · JTN
Difco Laboratories, Inc.
Microbiology · 79d
Cleared Oct 27, 1981
INTERMEDICS ADAPTAID STEP-DOWN ADAPTER
K812812 · DTD
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 27, 1981
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · KRG
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 27, 1981
IMED MODEL 970 & 975 VOL. INFUSION PUMP
K812823 · FRN
Imed Corp.
General Hospital · 19d
Cleared Oct 27, 1981
PRESSURE DISC COMPONENT FOR ACCUSET
K812824 · FRN
Imed Corp.
General Hospital · 19d
Cleared Oct 27, 1981
S/P SERUM DROPPER PIPETS
K812892 · KSS
American Dade
Hematology · 12d
Cleared Oct 26, 1981
FORCEP
K812205 · GEN
Reznik Instruments
General & Plastic Surgery · 83d
Cleared Oct 26, 1981
OXEQUIP CONDUCTIVE & NON ANES. BREATH
K812624 · CAI
Oxequip Health Ind.
Anesthesiology · 41d
Cleared Oct 26, 1981
ACMI BIPOLAR HEMOSTATIC SOURCE
K812637 · GEI
American Cystocope Makers, Inc.
General & Plastic Surgery · 41d
Cleared Oct 26, 1981
REPLACEABLE BATTERY PERFECTEMP 2 CAUT
K812644 · GEI
Key Medical, Inc.
General & Plastic Surgery · 39d
Cleared Oct 26, 1981
WHISK-R
K812694 · GEE
Medi-Spec
General & Plastic Surgery · 34d
Cleared Oct 26, 1981
THORACIC DRAINAGE SET #55-DB2-G
K812746 · KDQ
J. H. Emerson Co.
General Hospital · 27d
Cleared Oct 26, 1981
EXTENSIONS-LUSATZTISCH
K812779 · HST
The Telos Co.
Neurology · 21d
Cleared Oct 26, 1981
H-103 IGG, H-104 IGA, H-105 IGM
K812821 · DFZ
Immulok, Inc.
Immunology · 19d
Cleared Oct 26, 1981
FLO-COR I
K812825 · JAX
Biotrine Corp.
Anesthesiology · 18d
Cleared Oct 26, 1981
IDS PORPHYRIN REAGENT
K812859 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 13d