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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
147049–147072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 08, 1985
CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N
K853623
Co-Medical, Inc.
General & Plastic Surgery · 40d
Cleared Oct 08, 1985
GAUZE SPONGE
K853742 · GDY
South Mountain Medical
General & Plastic Surgery · 32d
Cleared Oct 08, 1985
MENISCAL STITCHING KIT
K853801
Aspen Laboratories, Inc.
General & Plastic Surgery · 27d
Cleared Oct 08, 1985
MENISCAL REPAIR SYSTEM
K853829
Concept, Inc.
General & Plastic Surgery · 25d
Cleared Oct 08, 1985
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
K853883 · HQC
Medical Corp. of America
Ophthalmic · 19d
Cleared Oct 08, 1985
SUTURE REMOVAL KIT
K853910 · KDD
Scientific & Medical Care Co.
General & Plastic Surgery · 18d
Cleared Oct 07, 1985
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700
K851405 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 181d
Cleared Oct 07, 1985
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199 · LYC
Osteotech, Inc.
Dental · 140d
Cleared Oct 07, 1985
FALCON (POWERED WHEELCHAIR)
K852381 · ITI
Venturego, Inc.
Physical Medicine · 124d
Cleared Oct 07, 1985
MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE
K852860 · GEX
Coherent Medical Group
General & Plastic Surgery · 91d