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
81697–81720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · DGC
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
K002561 · CZJ
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002563 · DEH
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002564 · DFH
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT...
K002577 · DWJ
Medivance, Inc.
Cardiovascular · 69d
Cleared Oct 26, 2000
ABX MICROS CRP
K002646 · GKZ
Abx Diagnostics
Hematology · 63d
Cleared Oct 26, 2000
HARDYDISK LOMEFLOXACIN, 10MCG
K002660 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK CEFOTETAN, 30MCG
K002661 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK LEVOFLOXACIN, 5MCG
K002664 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
NEUROTOLOGY DRAPE, MODEL TBD
K002702 · KKX
Gyrus Ent LLC
General Hospital · 57d
Cleared Oct 26, 2000
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
K002880 · IYN
Pie Medical
Radiology · 41d
Cleared Oct 26, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/FS
K003194 · FYA
Stackhouse, Inc.
General Hospital · 14d
Cleared Oct 26, 2000
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K003232 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 9d
Cleared Oct 26, 2000
LITEAIRE
K993101 · CAF
Thayer Medical Corp.
Anesthesiology · 406d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096 · GXR
Image-Guided Neurologics, Inc.
Neurology · 204d
Cleared Oct 25, 2000
PIPER
K001295 · MUJ
Rtek Medical Systems, LLC
Radiology · 184d
Cleared Oct 25, 2000
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K001493 · EFS
Air Force, Inc.
Dental · 166d
Cleared Oct 25, 2000
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
K001811 · FIP
Neu-Ion, Inc.
Gastroenterology & Urology · 132d
Cleared Oct 25, 2000
DIRECT CROWN
K001884 · EBG
Flexible Dimensions, LLC
Dental · 126d
Cleared Oct 25, 2000
CARDIOBEEPER CB12/12, MODEL CB12/12
K002310 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 86d
Cleared Oct 25, 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Oct 25, 2000
HARDYDISK STREPTOMYCIN, 300MCG
K002368 · JTN
Hardy Diagnostics
Microbiology · 83d
Cleared Oct 25, 2000
ACCESS ALERT GAUGE
K002372 · KOC
Medisystems Corp.
Gastroenterology & Urology · 82d