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
154129–154152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1984
AC ADAPTERS FOR BLOOD PRESSURE METERS
K833753 · DXN
Philips Park
Cardiovascular · 83d
Cleared Jan 30, 1984
ELECTRONIC DIGITAL FEVER THERMOMETER
K833755 · FLL
North American Philips Corp.
General Hospital · 96d
Cleared Jan 30, 1984
ANGIOTENSIN CONVERTING ENZYME
K833777 · CIB
Immuno-Diagnostic Laboratories
Chemistry · 95d
Cleared Jan 30, 1984
CHEM KIT PHENOBARBITAL
K833796 · DLZ
Abbott Laboratories
Toxicology · 90d
Cleared Jan 30, 1984
CHEMKIT PHENYTOIN DIAG. KIT
K833806 · DIP
Abbott Laboratories
Toxicology · 90d
Cleared Jan 30, 1984
ACTH RIA
K833849 · CKG
Syncor Intl. Corp.
Chemistry · 87d
Cleared Jan 30, 1984
COATEST ANTIPLASMIN
K833890 · LGP
Kabivitrum, Inc.
Hematology · 82d
Cleared Jan 30, 1984
COATEST HEPARIN
K833891 · KFF
Kabivitrum, Inc.
Hematology · 82d
Cleared Jan 30, 1984
COATEST FACTOR VIII
K833892 · GGP
Kabivitrum, Inc.
Hematology · 82d
Cleared Jan 30, 1984
INFUSION PORT BALLOON THERMODILUTION
K833918 · DYG
Critikon Company, LLC
Cardiovascular · 77d
Cleared Jan 30, 1984
CENTRICON MICRO-CONCENTRATOR
K833919 · JJH
Amicon, Inc.
Chemistry · 77d
Cleared Jan 30, 1984
ACETONE ALCOHOL SWABS
K833936 · LKB
Concord Laboratories, Inc.
General Hospital · 76d
Cleared Jan 30, 1984
PEGASUS MATTRESS
K833964 · FNM
Dermalex Co.
General Hospital · 75d
Cleared Jan 30, 1984
QUICK-COUNT
K833971 · GKL
Seragen Diagnostics, Inc.
Hematology · 75d
Cleared Jan 30, 1984
VENTREZYME THEOPHYLLINE IMMUNOASSAY
K833989 · KLS
Vxr, Inc.
Immunology · 73d
Cleared Jan 30, 1984
BIPOLAR HIP DEVICE
K833991 · KWY
Zimmer
Orthopedic · 70d
Cleared Jan 30, 1984
ALCOHOL SWABS
K833993 · LKB
Concord Laboratories, Inc.
General Hospital · 70d
Cleared Jan 30, 1984
QCA CHEMISTRY ANALYZER
K833998 · JJF
Bd Becton Dickinson Vacutainer...
Chemistry · 70d
Cleared Jan 30, 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026 · GKL
Technicon Instruments Corp.
Hematology · 69d
Cleared Jan 30, 1984
KINETIC ALKALINE PHOSPHATASE
K834033 · CJE
American Monitor Corp.
Chemistry · 68d
Cleared Jan 30, 1984
RIANEN FOLLICLE STIMULATING HORMONE
K834038 · CGJ
New England Nuclear
Chemistry · 68d
Cleared Jan 30, 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Jan 30, 1984
URIC ACID REAGENT SET
K834045 · KNK
Sterling Biochemical, Inc.
Chemistry · 68d
Cleared Jan 30, 1984
ENDAB T3
K834049 · CDP
Immunotech Corp.
Chemistry · 68d