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
80737–80760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2001
PERFECTA AND EXTEND
K004032 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 49d
Cleared Feb 15, 2001
DURABOND NON-PRECIOUS CERAMIC ALLOY
K010069 · EJH
Matech, Inc.
Dental · 38d
Cleared Feb 15, 2001
A & I WHEELCHAIRS
K010094 · IOR
Taiwan an I Co., Ltd.
Physical Medicine · 35d
Cleared Feb 15, 2001
COMFOR-CLINER
K010194 · IOR
Recliner Care, Inc.
Physical Medicine · 24d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · LZC
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Feb 15, 2001
TRI-FIT FEMORAL STEM
K010243 · LWJ
Corin USA
Orthopedic · 21d
Cleared Feb 14, 2001
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
K001329 · FPA
Lifemed of California
General Hospital · 293d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 208d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · DCN
Dade Behring, Inc.
Immunology · 104d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 14, 2001
TENSCARE, MODEL TENS XL-2
K003591 · GZJ
Tenscare, Ltd.
Neurology · 85d
Cleared Feb 14, 2001
DELFIA NEONATAL IRT KIT, MODEL A005-110
K003664 · CGZ
Wallac OY
Chemistry · 78d
Cleared Feb 14, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667 · MXC
Medtronic Vascular
Cardiovascular · 78d
Cleared Feb 14, 2001
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND...
K003695 · HRX
Micro-Medical Devices, Inc.
Orthopedic · 76d
Cleared Feb 14, 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 72d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · MTD
Boston Scientific Corp
Cardiovascular · 69d
Cleared Feb 14, 2001
BIOLUCENT MAMMOGRAPHY CUSHION
K003795 · IZH
Biolucent, Inc.
Radiology · 68d
Cleared Feb 14, 2001
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
K003936 · IYO
Tomtec Imaging Systems GmbH
Radiology · 56d
Cleared Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
K004002 · JHX
Diagnostic Products Corp.
Chemistry · 50d
Cleared Feb 14, 2001
LC PROVIFILL
K010012 · EBG
S & C Polymer GmbH
Dental · 43d
Cleared Feb 14, 2001
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
K010030 · JIX
Synergent Biochem Inc.-Clinical...
Chemistry · 42d
Cleared Feb 14, 2001
TEKNIQUE
K010075 · ITI
Hoveround Corp.
Physical Medicine · 36d
Cleared Feb 14, 2001
PROFILE II ER
K010138 · LDJ
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Feb 14, 2001
KIMAX, MODEL 1024
K010187 · JAA
Medical Metrics, Inc.
Radiology · 23d