Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
156121–156144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1983
PATIENT MONITOR #78832A
K831944 · DRT
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 19, 1983
HARD CONTACT LENS CASE
K831973 · HPX
Moonbeam International, Inc.
Ophthalmic · 121d
Cleared Oct 19, 1983
ACCU-SPHYG
K832060 · DXN
Olympic Medical Corp.
Cardiovascular · 114d
Cleared Oct 19, 1983
CODY SACCULOTOMY TACK
K832068 · ESX
Micromedics, Inc.
Ear, Nose, Throat · 114d
Cleared Oct 19, 1983
SURGICAL STOCKINGS
K832273 · DWL
Wells Johnson Co.
General Hospital · 99d
Cleared Oct 19, 1983
NOVA BALLOON THERMODILUTION INFUSION
K832287 · DYG
Nova Medical Specialties
Cardiovascular · 98d
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