FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79633–79656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 13, 2001
MOJAVE CATARACT EXTRACTION SYSTEM
K003638 · HQC
Allergan, Inc.
Ophthalmic · 81d
Cleared Feb 13, 2001
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES...
K003833 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 64d
Cleared Feb 13, 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 63d
Cleared Feb 13, 2001
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 42d
Cleared Feb 13, 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Feb 13, 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · DQY
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Feb 13, 2001
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER...
K010340 · LNS
Karl Storz Lithotripsy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 12, 2001
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · JEY
Walter Lorenz Surgical, Inc.
Dental · 217d
Cleared Feb 12, 2001
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
K003510 · LLZ
Visualization Technology, Inc.
Radiology · 90d