FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80137–80160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 14, 2001
OFFSET TIBIAL TRAY
K010212 · MBV
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237 · JJX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Feb 14, 2001
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP,...
K010246 · HRX
Kyphon, Inc.
Orthopedic · 19d
Cleared Feb 14, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K010342 · MWI
Agilent Technologies, Inc.
Cardiovascular · 9d
Cleared Feb 14, 2001
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308,...
K010343 · DZE
Buck Medical Research
Dental · 9d
Cleared Feb 13, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K001585 · LPL
American Biocurve, Inc.
Ophthalmic · 267d
Cleared Feb 13, 2001
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
K002583 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 179d
Cleared Feb 13, 2001
SALUTE
K003522 · GDW
Onux Medical, Inc.
General & Plastic Surgery · 90d