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
147409–147432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1985
MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
K851664 · DXN
Sharp Electronics Corp.
Cardiovascular · 92d
Cleared Jul 24, 1985
THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI
K852100 · FPD
Henley Board, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 24, 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414 · DIF
Bio-Rad
Toxicology · 48d
Cleared Jul 24, 1985
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
K852593 · EFS
Northern Electric Co. Div. of Sunbeam...
Dental · 35d
Cleared Jul 24, 1985
ETEN-GEL
K852658 · EBF
Dentsply Intl.
Dental · 30d
Cleared Jul 24, 1985
XEN-REX I
K852693 · IYT
Nuclear Pharmacy, Inc.
Radiology · 28d
Cleared Jul 24, 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841 · GTZ
Smithkline Diagnostics, Inc.
Microbiology · 19d
Cleared Jul 24, 1985
AM FAB SIDE RAILS MODEL 5000
K852890 · FNJ
Am Fab, Inc.
General Hospital · 15d
Cleared Jul 24, 1985
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903 · FLL
Toshiba Medical Systems
General Hospital · 15d
Cleared Jul 23, 1985
R PAK
K851203 · LFL
CooperVision, Inc.
General & Plastic Surgery · 119d
Cleared Jul 23, 1985
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
K851641 · MSJ
Ortho Diagnostic Systems, Inc.
Hematology · 95d
Cleared Jul 23, 1985
HGM ENDOCOAGULATOR MODEL 8
K851651
Hgm, Inc.
General & Plastic Surgery · 92d
Cleared Jul 23, 1985
QUICK-COUNT HEMATOLOGY CONTROLS
K851663 · JPK
Seragen Diagnostics, Inc.
Hematology · 91d
Cleared Jul 23, 1985
MONITOR IV PLUS
K851669 · JOZ
Helena Laboratories
Hematology · 91d
Cleared Jul 23, 1985
OPSITE WOUND DRESSING
K852211 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 63d
Cleared Jul 23, 1985
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
K852539 · LFL
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 39d
Cleared Jul 23, 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · FMF
Sherwood Medical Co.
General Hospital · 39d
Cleared Jul 23, 1985
MONOJECT STERILE 60CC SYRINGES
K852580 · FMF
Sherwood Medical Co.
General Hospital · 35d
Cleared Jul 23, 1985
MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES
K852588 · FMF
Sherwood Medical Co.
General Hospital · 35d
Cleared Jul 23, 1985
MONJECT STERILE 20CC SYRINGES
K852607 · FMF
Sherwood Medical Co.
General Hospital · 34d
Cleared Jul 23, 1985
MONOJECT STERILE 35CC SYRINGES
K852640 · FMF
Sherwood Medical Co.
General Hospital · 33d
Cleared Jul 23, 1985
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE
K852752 · CJE
American Research Products Co.
Chemistry · 25d
Cleared Jul 23, 1985
TECHNICON H*1 SYSTEM
K852787
Technicon Instruments Corp.
Hematology · 22d
Cleared Jul 23, 1985
CHOLESTEROL METHOD
K852863 · CHH
Catachem, Inc.
Chemistry · 15d