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
155281–155304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1983
BABY LIGHT DOSIMETER
K832298 · LBI
Rocky Mountain Medical Corp.
General Hospital · 97d
Cleared Oct 19, 1983
PERCLUDER DL OCCLUDING BALLOON
K832386 · DQO
Datascope Corp.
Cardiovascular · 92d
Cleared Oct 19, 1983
CATAREX DIAP. EXTRACAPSULAR CATARACT
K832446 · HQE
Calliope Corp.
Ophthalmic · 86d
Cleared Oct 19, 1983
AXIOM PERFUSSION CANNULA
K832475 · DWF
Axiom Medical, Inc.
Cardiovascular · 85d
Cleared Oct 19, 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
K832561 · LDF
Cordis Corp.
Cardiovascular · 79d
Cleared Oct 19, 1983
TOP THREE WAY STOPCOCK
K832625 · DTL
Top Surgical Manufacturers Co.
Cardiovascular · 76d
Cleared Oct 19, 1983
SATELEC SUPRASSON SP 3055
K832665 · ELC
Spelna, Inc.
Dental · 71d
Cleared Oct 19, 1983
SATELEC PROPHY UNIT PU-2000
K832673 · EIA
Spelna, Inc.
Dental · 71d
Cleared Oct 19, 1983
AIR FLUID EXCHANGE PUMP
K832761 · FMF
Intek Int'L, Inc.
General Hospital · 61d
Cleared Oct 19, 1983
CURAY-SUPPORT, CORE BUILD-UP MATERIAL
K832781 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 64d
Cleared Oct 19, 1983
PEDIATRIC ILLUMINATING URETERAL
K832807 · FCW
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 19, 1983
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR
K832850 · LDF
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Oct 19, 1983
HEMACOMP 7 OR HEMATIL 7
K832890 · GKL
Texas Intl. Laboratories, Inc.
Hematology · 54d
Cleared Oct 19, 1983
OCUTOME PARATUBING SET
K832938
Vxtra Corp.
Ophthalmic · 47d
Cleared Oct 19, 1983
EAGLE 2000 STERILIZER SERIES GAS/AERA
K832945 · FLF
Amsco Co.
General Hospital · 50d
Cleared Oct 19, 1983
SCIENTRONICS 10K EYE MAGNET
K832950 · HPO
Scientific Manufacturer
Ophthalmic · 49d
Cleared Oct 19, 1983
VXTRA OCUTOME KIT
K832980 · HQC
Vxtra Corp.
Ophthalmic · 47d
Cleared Oct 19, 1983
PERCUTANEOUS NEPHROSTOMY CATHETER
K833008 · LJE
Medical Engineering Corp.
Gastroenterology & Urology · 43d
Cleared Oct 19, 1983
GASTRIC SUMP TUBES
K833054 · KNT
Medovations, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108 · DTB
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
DEFLECTING GUIDE WIRE
K833242 · KNY
Van-Tec, Inc.
Gastroenterology & Urology · 62d