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
146449–146472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1985
DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
K851635 · GQL
Diagnon Corp.
Microbiology · 175d
Cleared Oct 10, 1985
PC INTERFACE
K852771 · CBK
Siemens Elema AB
Anesthesiology · 105d
Cleared Oct 10, 1985
GAS EVACUATION ACCESSORY
K852772 · CBN
Siemens Elema AB
Anesthesiology · 105d
Cleared Oct 10, 1985
FDP ASSAY-20 TEST KIT
K852848 · GHH
American Bioproducts Co.
Hematology · 97d
Cleared Oct 10, 1985
OPTICAL DISC UNIT
K852865 · JAK
General Electric Co.
Radiology · 94d
Cleared Oct 10, 1985
QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
K852920 · GZB
Neuromed, Inc.
Neurology · 92d
Cleared Oct 10, 1985
ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411
K852935 · GEI
Eschmann Bros. & Walsh , Ltd.
General & Plastic Surgery · 92d
Cleared Oct 10, 1985
WORLD PORTABLE CAUTERY
K852942 · GEI
Sturgeon Engineering Co.
General & Plastic Surgery · 92d
Cleared Oct 10, 1985
PARA CHECK (AKA EIGHT CHECK-C)
K852992 · JPK
Streck Laboratories, Inc.
Hematology · 87d
Cleared Oct 10, 1985
PRESSURE GAUGE
K853040 · BXH
Erie Medical
Anesthesiology · 83d
Cleared Oct 10, 1985
REI-90/15
K853175 · IXR
Radiological Engineering, Inc.
Radiology · 72d
Cleared Oct 10, 1985
MST-1050-II X-RAY UNIT
K853210 · KPA
Radiological Engineering, Inc.
Radiology · 71d
Cleared Oct 10, 1985
GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300
K853291 · HAM
Bio-Detek, Inc.
General & Plastic Surgery · 66d
Cleared Oct 10, 1985
COULTER COUNTER MODEL M5
K853429 · GKL
Coulter Electronics, Inc.
Hematology · 56d
Cleared Oct 10, 1985
FINGER TOURNIQUETTE
K853472 · GAX
Joseph B. Marogil
General & Plastic Surgery · 51d
Cleared Oct 10, 1985
SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030
K853622
Kleen Test Products
General & Plastic Surgery · 42d
Cleared Oct 10, 1985
SPLASH ADAPTOR
K853665 · BYH
Ohio Medical Research, Inc.
Anesthesiology · 37d
Cleared Oct 10, 1985
CITREX H
K853897 · GGW
Bio/Data Corp.
Hematology · 20d
Cleared Oct 10, 1985
LX 300 TISSUE PROCESSOR
K853938 · IEO
Innovative Medical Systems, Inc.
Pathology · 16d
Cleared Oct 09, 1985
ELECTROCARDIOGRAPH
K852181 · DPS
Armstrong Ind., Inc.
Cardiovascular · 142d
Cleared Oct 09, 1985
SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER
K852281 · DPS
Armstrong Ind., Inc.
Cardiovascular · 133d
Cleared Oct 09, 1985
SCHILLER MINISCOPE MS-2 EKG SCOPE
K852282 · DPS
Armstrong Ind., Inc.
Cardiovascular · 133d
Cleared Oct 08, 1985
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
K853520 · DTB
Intermedics, Inc.
Cardiovascular · 47d
Cleared Oct 08, 1985
CANTROL URINE DIPSTICK CONTROL TWO LEVELS
K853603 · JJW
Canyon Diagnostics, Inc.
Chemistry · 41d