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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
46201–46224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2011
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
K111354 · MAX
GS Medical Co., Ltd.
Orthopedic · 157d
Cleared Oct 17, 2011
MICROGARD II
K111408 · CAH
Carefusion Germany 234 GmbH
General Hospital · 151d
Cleared Oct 17, 2011
CORONIS 5MP
K111990 · LLZ
Barco N.V.
Radiology · 96d
Cleared Oct 17, 2011
ZYSTON STRAIGHT SPACER SYSTEM
K112014 · MAX
Biomet Spine
Orthopedic · 95d
Cleared Oct 17, 2011
8FR TURBO - TANDEM SYSTEM
K112032 · DQY
Spectranetics Corp.
Cardiovascular · 94d
Cleared Oct 17, 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K112156 · JXG
Medos International SARL
Neurology · 82d
Cleared Oct 17, 2011
UNIMAX TROCAR SYSTEM
K112358 · GCJ
Unimax Medical Systems, Inc.
General & Plastic Surgery · 62d
Cleared Oct 17, 2011
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
K112439 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Oct 17, 2011
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
K112710 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 28d
Cleared Oct 17, 2011
EZ VEIN INFLATABLE TOURNIQUET
K112874 · KCY
Dominion Medical Devices, LLC
General & Plastic Surgery · 17d
Cleared Oct 14, 2011
RANDOX DIGOXIN ASSAY
K102346 · KXT
Randox Laboratories, Ltd.
Chemistry · 421d
Cleared Oct 14, 2011
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · KLT
Abbott Laboratories
Toxicology · 305d
Cleared Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · LON
bioMerieux, Inc.
Microbiology · 295d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135 · LPH
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Oct 14, 2011
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
K110250 · LYY
Total Gloves Sdn Bhd
General Hospital · 259d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 227d
Cleared Oct 14, 2011
CSM SUBMERGED-R IMPLANT SYSTEM
K111120 · DZE
Csm Implant
Dental · 176d
Cleared Oct 14, 2011
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
K111436 · FTM
Brennen Medical, LLC
General & Plastic Surgery · 143d
Cleared Oct 14, 2011
TRILOGY SERIES VENTILATOR WITH OXIMETRY
K111610 · CBK
Respironics, Inc.
Anesthesiology · 127d
Cleared Oct 14, 2011
DISPOSABLE ELECTRODE
K111737 · GXY
Sanibel Supply
Neurology · 115d
Cleared Oct 14, 2011
GLADIATOR HIP STEM
K111910 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 101d
Cleared Oct 14, 2011
TETRIC EVOCERAM BULK FILL
K111958 · EBF
Ivoclar Vivadent, Inc.
Dental · 95d
Cleared Oct 14, 2011
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K111975 · KLE
Kuraray Medical, Inc.
Dental · 94d
Cleared Oct 14, 2011
CLEARFIL TRI-S BOND PLUS
K111980 · KLE
Kuraray America, Inc.
Dental · 94d