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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
41809–41832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2012
XPERT CT/NG
K121710 · LSL
Cepheid
Microbiology · 199d
Cleared Dec 27, 2012
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
K122039 · EBG
Kettenbach GmbH & Co. KG
Dental · 169d
Cleared Dec 27, 2012
FLEXLITE CAMERA
K122134 · HRX
Spine View, Inc.
Orthopedic · 162d
Cleared Dec 27, 2012
PRESTIGE-MOBIE
K122749 · INI
Prestige Sporting Goods Co. , Ltd.
Physical Medicine · 111d
Cleared Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
K122784 · GZI
Bioness, Inc.
Neurology · 107d
Cleared Dec 27, 2012
SYNGO SINGLE SOURCE DUAL ENGERY
K122909 · JAK
Siemens Medical Systems, Inc.
Radiology · 97d
Cleared Dec 27, 2012
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
K123091 · MOS
Imris, Inc.
Radiology · 86d
Cleared Dec 27, 2012
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
K123419 · MUH
Afp Imaging Corp.
Radiology · 51d
Cleared Dec 27, 2012
CLEARREAD +CONFIRM
K123526 · LLZ
Riverain Technologies
Radiology · 42d
Cleared Dec 27, 2012
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · DRA
Medtronic Cryocath, LP
Cardiovascular · 36d
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Dec 27, 2012
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
K123683 · MXA
Aerocrine AB
Chemistry · 27d
Cleared Dec 26, 2012
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
K123017 · FRC
Advanced Sterilization Products
General Hospital · 89d
Cleared Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898 · LPH
Lima Corporate S.P.A.
Orthopedic · 445d
Cleared Dec 21, 2012
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
K113010 · IPF
Famidoc Technology Co., Ltd.
Physical Medicine · 437d
Cleared Dec 21, 2012
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
K113023 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 437d
Cleared Dec 21, 2012
MR4500 WHEELCHAIR
K120391 · IOR
Wardray Premise, Ltd.
Physical Medicine · 318d
Cleared Dec 21, 2012
ANESTHESIA CONDUCTION NEEDLES
K120475 · BSP
Shanghai Samedical & Plastic...
Anesthesiology · 309d
Cleared Dec 21, 2012
Z-LOOK3 EVO SLM
K120793 · DZE
Z-Systems AG
Dental · 281d
Cleared Dec 21, 2012
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT...
K120822 · NHA
Institut Straumann AG
Dental · 277d
Cleared Dec 21, 2012
PREXION 3D
K120948 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 267d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Dec 21, 2012
NHANCER
K121077 · DQY
Imds Operations B.V.
Cardiovascular · 256d
Cleared Dec 21, 2012
CENTURION VISION SYSTEM
K121555 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 210d