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
173905–173928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1977
VENOSET FOR I.V. FAT EMULSION
K770051 · FPA
Abbott Laboratories
General Hospital · 29d
Cleared Feb 08, 1977
CAMCO R PAK-GUAIAC
K770153 · KHE
Cambridge Chemical Products, Inc.
Hematology · 15d
Cleared Feb 08, 1977
STOCKINETTE
K770173 · ILG
Chase Mfg. Co.
Physical Medicine · 13d
Cleared Feb 08, 1977
BI-CENTRIC ENDOPROSTHESES
K770184 · JDG
Howmedica Corp.
Orthopedic · 12d
Cleared Feb 08, 1977
HAND REAMERS
K770203 · HTO
Depuy, Inc.
Orthopedic · 8d
Cleared Feb 08, 1977
CEMENT EXTRACTOR DRILL
K770204 · HXY
Depuy, Inc.
Orthopedic · 8d
Cleared Feb 08, 1977
CEMENT CHISELS
K770205 · HWA
Depuy, Inc.
Orthopedic · 8d
Cleared Feb 08, 1977
GRASPING FORCEPS
K770206 · HTD
Depuy, Inc.
General & Plastic Surgery · 8d
Cleared Feb 07, 1977
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
K761058 · GGP
Bio/Data Corp.
Hematology · 81d
Cleared Feb 07, 1977
MICROSAMPLE BLOOD COLLECTION DEVICE
K761137 · GKH
Ortho Diagnostics, Inc.
Hematology · 75d
Cleared Feb 07, 1977
ABSORPTION SPECTROPHOTOMETERS
K761316 · JXR
The Perkin-Elmer Corp.
Toxicology · 42d
Cleared Feb 07, 1977
HGA-2200 HEATED GRAPHITE ATOMIZER
K761317
The Perkin-Elmer Corp.
Toxicology · 42d
Cleared Feb 07, 1977
SPAC TM T3 UPTAKE KIT
K770033 · KHQ
Mallinckrodt Critical Care
Immunology · 28d
Cleared Feb 07, 1977
LEAD MODIFICATION
K770135 · DXY
Elema-Schonander, Inc.
Cardiovascular · 14d
Cleared Feb 07, 1977
SPAC TM T4 RIA KIT
K770156 · CDX
Mallinckrodt Critical Care
Immunology · 14d
Cleared Feb 07, 1977
DEVILBISS OXYGEN ENRICHER
K770157 · CAW
The Devilbiss Co.
Anesthesiology · 14d
Cleared Feb 07, 1977
PELLET, CALIBRATION
K770172
Deringer-Ney, Inc.
Dental · 12d
Cleared Feb 07, 1977
PERM. IMPLANT. ENDOCARDIAL PAC. LEAD
K770195 · DTB
Daig Corp.
Cardiovascular · 7d
Cleared Feb 07, 1977
UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR
K770197 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 07, 1977
BIPOLAR ASYNCHRONOUS PULSE GENERATOR
K770198 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 07, 1977
LEAD EXTENDER MODEL 6516
K770199 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 07, 1977
CTM (CLINAC TREATMENT MONITOR)
K770202 · KPQ
Varian Assoc., Inc.
Radiology · 7d
Cleared Feb 07, 1977
BARIOR
K770213 · KOC
Tri-Med, Inc.
Gastroenterology & Urology · 5d
Cleared Feb 04, 1977
SEA-BOND ADHEVISE DENTURE CUSHIONS
K770175 · KKX
Combe, Inc.
General Hospital · 9d