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
168337–168360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1979
BE-SURE
K791609 · JHJ
Biologics Intl., Inc.
Chemistry · 53d
Cleared Oct 02, 1979
VICKERS MEDICAL MODEL 112 TREONIC DC2
K791645 · FKW
Vickers America Medical Corp.
Gastroenterology & Urology · 40d
Cleared Oct 02, 1979
CUSTOM DRESSING CHANGE TRAYS
K791738 · FMC
Sterile Design, Inc.
General Hospital · 33d
Cleared Oct 02, 1979
ULTIPOR BLOOD FILTER EXTRA-CORPOREAL
K791748 · DTM
Pall Biomedical Products Co.
Cardiovascular · 22d
Cleared Oct 02, 1979
IPAG MICRONOVA INTERFACE #781111
K791753 · DXG
Robinton Corp.
Cardiovascular · 27d
Cleared Oct 02, 1979
ARRHYTHMIA II EDITOR
K791776 · DQK
Spacelabs, Inc.
Cardiovascular · 22d
Cleared Oct 02, 1979
MEDTRONIC MODEL 9410 TELETRACE RECEIVER
K791778 · DXH
Medtronic Vascular
Cardiovascular · 22d
Cleared Oct 02, 1979
SHILEY QUICK DISCONNECT ASSEMBLY
K791829 · KRI
Shiley, Inc.
Cardiovascular · 15d
Cleared Oct 02, 1979
NURITE II VRM SINGLE (ELEC. NERVE STIM)
K791833 · GZJ
Bio-Medical Systems Corp.
Neurology · 15d
Cleared Oct 02, 1979
NURITE II VRM DUAL (ELEC. NERVE STIM.)
K791834 · GZJ
Bio-Medical Systems Corp.
Neurology · 15d
Cleared Oct 02, 1979
CRITIFLO & CRITIFLO DOME
K791844 · KRA
Gould, Inc.
Cardiovascular · 13d
Cleared Oct 02, 1979
DISPOSSABLE SUCTION TUBE, 6 FRENCH
K791846 · DTS
Dlp, Inc.
Cardiovascular · 13d
Cleared Oct 02, 1979
ASPRI-LUKE
K791847 · BYZ
Medical Marketing Group
General Hospital · 13d
Cleared Oct 02, 1979
MAC LEE ENEMAD
K791863 · FCE
Mac Lee Medical Products
Gastroenterology & Urology · 8d
Cleared Oct 02, 1979
JELCO WINGED INTRAVASCULAR CATHETER
K791918 · FOZ
Jelco Laboratories
General Hospital · 7d
Cleared Oct 01, 1979
INTRA-AORTIC BALLOON, TYPE S
K790775 · DSP
Datascope Corp.
Cardiovascular · 164d
Cleared Oct 01, 1979
PLASTIC SHOWER GUARD
K791646 · KIA
B & F Medical Products, Inc.
General Hospital · 38d
Cleared Oct 01, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791663 · CDP
Immuchem Corp.
Chemistry · 41d
Cleared Oct 01, 1979
ENDOSCOPIC CYTOLOGY BRUSHES
K791668 · FDX
Mill-Rose Laboratory
Gastroenterology & Urology · 34d
Cleared Oct 01, 1979
SABOURAUD AGAR MODIFIED
K791670 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Oct 01, 1979
DNASE TEST AGAR
K791671 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Oct 01, 1979
CDC ANAEROBIC SHEEP BLOOD AGAR (BA)
K791698 · JSG
Gibco Laboratories Life Technologies,...
Microbiology · 34d
Cleared Oct 01, 1979
CORTI-SHURE
K791700 · CGR
Nuclear Medical Laboratories, Inc.
Chemistry · 33d
Cleared Oct 01, 1979
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723 · JJT
Organon, Inc.
Chemistry · 32d