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
42361–42384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292 · KWP
Reliance Medical Systems, LLC
Orthopedic · 85d
Cleared Oct 24, 2012
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED...
K122422 · PNG
Care Fusion
Gastroenterology & Urology · 76d
Cleared Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Oct 24, 2012
CDC ZIRCONIA BLANKS
K122972 · EIH
Continental Dental Ceramics, Inc....
Dental · 28d
Cleared Oct 24, 2012
BIOMET LATERAL SPACER SYSTEM
K122989 · MAX
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 28d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 23, 2012
HX-461
K120545 · DXN
Seers Technology Co., Ltd.
Cardiovascular · 243d
Cleared Oct 23, 2012
FORTEX PEDICLE SCREW SYSTEM
K120832 · MNH
X-Spine Systems, Inc.
Orthopedic · 218d
Cleared Oct 23, 2012
RESOLUTE FACET SCREW SYSTEM
K121551 · MRW
Neurostructures, LLC
Orthopedic · 151d
Cleared Oct 23, 2012
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY...
K121657 · IYE
Proton Systems
Radiology · 140d
Cleared Oct 23, 2012
GEO
K121705 · BZD
Resmed, Ltd.
Anesthesiology · 137d
Cleared Oct 23, 2012
NUVASIVE SAGE LATERAL PLATE SYSTEM
K121815 · KWQ
Nuvasive, Inc.
Orthopedic · 125d
Cleared Oct 23, 2012
AURICAL HIT
K122028 · ETW
Gn Otometrics
Ear, Nose, Throat · 105d
Cleared Oct 23, 2012
MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
K122092 · GEI
Medrange Corporation
General & Plastic Surgery · 99d
Cleared Oct 23, 2012
IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
K122280 · OHT
Cyden Limited
General & Plastic Surgery · 85d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Carestream Health, Inc.
Radiology · 64d
Cleared Oct 23, 2012
OSSEOFLEX SB INFLATABLE BONE TAMP
K122533 · NDN
Osseon Therapeutics, Inc.
Orthopedic · 64d
Cleared Oct 23, 2012
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · GDW
Covidien
General & Plastic Surgery · 19d
Cleared Oct 22, 2012
PHASIX PLUG AND PATCH
K120728 · OWT
C.R. Bard, Inc.
General & Plastic Surgery · 227d
Cleared Oct 22, 2012
XN CAL PF
K120747 · KRX
Streck
Hematology · 224d
Cleared Oct 22, 2012
CPRMETER CPR FEEDBACK DEVICE
K122050 · LIX
Laerdal Medical A/S
Cardiovascular · 102d
Cleared Oct 22, 2012
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS...
K122277 · HRY
Biomet Manufacturing Corp
Orthopedic · 84d
Cleared Oct 22, 2012
DYNASTY BIOFOAM SHELL
K122382 · MBL
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Oct 22, 2012
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K122482 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 69d