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
141241–141264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1987
TRI-LOCK LONG STEM MODULAR NECK
K864331
Depuy, Inc.
Orthopedic · 63d
Cleared Jan 06, 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · DYB
Quinton, Inc.
Cardiovascular · 63d
Cleared Jan 06, 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K864468 · BSY
Sheridan Catheter Corp.
Anesthesiology · 55d
Cleared Jan 06, 1987
MODIFIED RLV-2100 B
K864503 · DWD
American Omni Medical, Inc.
Cardiovascular · 53d
Cleared Jan 06, 1987
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K864535 · BSY
Concord Laboratories, Inc.
Anesthesiology · 50d
Cleared Jan 06, 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 43d
Cleared Jan 06, 1987
MODIFIED ESCHMANN DILATATION CATHETER
K864637
Eschmann Bros. & Walsh , Ltd.
Cardiovascular · 48d
Cleared Jan 06, 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · DTB
Cordis Corp.
Cardiovascular · 41d
Cleared Jan 06, 1987
SALT CREEK P.I. TRAY
K864682
Salt Creek Medical Technologies
Cardiovascular · 35d
Cleared Jan 06, 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738 · DTB
Intermedics, Inc.
Cardiovascular · 33d
Cleared Jan 06, 1987
BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1
K864823 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 06, 1987
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
K864856 · DTB
Medtronic Vascular
Cardiovascular · 26d
Cleared Jan 06, 1987
ICU/CPU TRANSPORT TRAY
K864878 · FNJ
Orthopedic Systems, Inc.
General Hospital · 25d
Cleared Jan 05, 1987
METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME
K853952 · DPW
Metriflow, Inc.
Radiology · 467d
Cleared Jan 05, 1987
1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER
K861205 · DSB
Valhalla Scientific
Cardiovascular · 280d
Cleared Jan 05, 1987
EUB-310 ULTRASONIC SCANNER
K862867 · IYO
Hitachi Medical Corp. of America
Radiology · 160d
Cleared Jan 05, 1987
DALTEX IV INFUSION PUMP
K863470 · FRN
Daltex Medical Sciences, Inc.
General Hospital · 119d
Cleared Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
K864211 · KFF
Instrumentation Laboratory CO
Hematology · 69d
Cleared Jan 05, 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · CGA
Abbott Laboratories
Chemistry · 69d
Cleared Jan 05, 1987
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
K864333 · KXT
Windsor Laboratories, Inc.
Toxicology · 62d
Cleared Jan 05, 1987
PROTIME AUTOMATE TEST KIT
K864392 · GJS
American Bioproducts Co.
Hematology · 60d
Cleared Jan 05, 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
K864481 · GGP
Instrumentation Laboratory CO
Hematology · 53d
Cleared Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · GGP
Instrumentation Laboratory CO
Hematology · 52d
Cleared Jan 05, 1987
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · GKF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 41d