FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
160033–160056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 02, 1982
PACEMAKER CONNECTOR PLUG
K821548 · DTD
Pacesetter Systems
Cardiovascular · 8d
Cleared Jun 02, 1982
PACEMAKER 445 ADAPTER
K821549 · DTD
Pacesetter Systems
Cardiovascular · 8d
Cleared Jun 02, 1982
ENDOSCOPIC ACCESSORY U/S/ CLEANING MACHINE
K827507
Keymed House
Radiology · 50d
Cleared Jun 01, 1982
SPAC T4 RIA TEST KIT
K820725 · CDX
Mallinckrodt Critical Care
Chemistry · 76d
Cleared Jun 01, 1982
KENZ-45M
K820854 · DXN
Suzuken Co., Ltd.
Cardiovascular · 67d
Cleared Jun 01, 1982
SAFE-T-SEAL
K820857 · GEI
Wisconsin Scientific Corp.
General & Plastic Surgery · 64d