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
160873–160896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1982
INTERPULSE MEMBRANE OXYGENATOR
K821216 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 36d
Cleared Jun 02, 1982
#2010 CAMPHYLOBACTER AGAR
K821300 · JSI
Biomedia, Inc.
Microbiology · 29d
Cleared Jun 02, 1982
RETIC SET
K821318 · KJN
R&D Systems, Inc.
Hematology · 29d
Cleared Jun 02, 1982
HEMATOXYLIN STAIN
K821320 · HYJ
Sigma Chemical Co.
Pathology · 29d
Cleared Jun 02, 1982
ATRIAL J TEMPORARY PACING ELECTRODESS
K821333 · LDF
Medics Instrument Corp.
Cardiovascular · 28d
Cleared Jun 02, 1982
GLYCO-GEL TEST KIT
K821360 · LCP
Pierce Chemical Co.
Hematology · 26d
Cleared Jun 02, 1982
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K821371 · FOZ
Warner-Lambert Co.
General Hospital · 23d
Cleared Jun 02, 1982
DESERET INTRACATH INTRAVENOUS CATHETER
K821372 · FOZ
Warner-Lambert Co.
General Hospital · 23d
Cleared Jun 02, 1982
EMIT TOX ACETAMINOPHEN CONTROL
K821380 · LAS
Syva Co.
Toxicology · 23d
Cleared Jun 02, 1982
PREG/TEX PREGNANCY TEST
K821387 · JHJ
Texas Immunology, Inc.
Immunology · 23d
Cleared Jun 02, 1982
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433 · CIT
Beckman Instruments, Inc.
Chemistry · 21d
Cleared Jun 02, 1982
FORMICAL
K821443 · KDX
Lerner Laboratories, Inc.
Chemistry · 19d
Cleared Jun 02, 1982
ULTRACHEM E-GLU, #64976 & 65040
K821461 · CFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
K821463 · LFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
CARDIOZYME PLUS CK-MB, #65045
K821464 · CGS
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM URIC ACID AIDH, #65047
K821465 · CDO
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRAZYME PLUS-GT, #64959 & 65032
K821468 · JPZ
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
K821469 · LFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM E-GLU #64976 & 65040
K821470 · CFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRAZYME PLUS ALP #64962,65029&65030
K821471 · CJE
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
STERILE HD PAN SET
K821482 · FRG
Hospital Disposables, Inc.
General Hospital · 15d
Cleared Jun 02, 1982
SILKAFIX ADHESIVE PLASTER
K821490 · KGX
Selomas, Inc.
General & Plastic Surgery · 15d
Cleared Jun 02, 1982
MODEL 379 FLOW/DIVIDER
K821520 · CAW
Marathon
Anesthesiology · 12d
Cleared Jun 02, 1982
PACEMAKER UNIPOLAR ADAPTER
K821547 · DTD
Pacesetter Systems
Cardiovascular · 8d