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
140089–140112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · LIO
Bio-Rad
Microbiology · 16d
Cleared May 29, 1987
THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION
K871911 · JAA
F. Spoon Co.
Radiology · 11d
Cleared May 29, 1987
MICROLAB AT
K871945 · JTC
Hamilton Co.
Microbiology · 10d
Cleared May 28, 1987
ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)
K870016 · DTB
Migada, Ltd.
Cardiovascular · 146d
Cleared May 28, 1987
AFFINITY (TM) HCG IMMUNIT (TM)
K870627 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 104d
Cleared May 28, 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared May 28, 1987
DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
K871068 · KKX
Lifestream Int'L, Inc.
General Hospital · 71d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60081 120 NA/2K
K871182 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60082 140 NA/5K
K871183 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60083 160 NA/8K
K871184 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
K871185 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
CESIUM DILUENT 1.5 MMOL CS/L #60087
K871186 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
K871187 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
K871188 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C
K871207 · DXN
Omron Electronics, Inc.
Cardiovascular · 64d
Cleared May 28, 1987
SYPHILIS SEROLOGICAL REAGENTS
K871226 · GMQ
New Horizons Diagnostics Co.
Microbiology · 62d
Cleared May 28, 1987
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
K871484 · LGS
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared May 28, 1987
TRU-SOUND ULTRASOUND THERAPY UNIT
K871633 · IMJ
Tru-Trac Therapy Products, Inc.
Physical Medicine · 31d
Cleared May 28, 1987
IMS-2000S STRESS MONITOR
K871659 · DXG
Integrated Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 28, 1987
LD PRESUMPTO QUAD
K871907 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared May 27, 1987
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D
K863969 · DXO
Camino Laboratories, Inc.
Cardiovascular · 225d
Cleared May 27, 1987
TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT
K870412 · DQY
Medical Surgical Concepts, Inc.
Cardiovascular · 113d
Cleared May 27, 1987
CANNULATED INSTRUMENT CLEANERS
K870765 · EKW
Treace Medical, Inc.
Dental · 90d
Cleared May 27, 1987
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 85d