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
41281–41304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2013
NAUTILUS SPINAL SYSTEM
K123373 · NKB
Life Spine
Orthopedic · 125d
Cleared Mar 05, 2013
ULTRASONIC SCALER
K113717 · ELC
Nakanishi, Inc.
Dental · 442d
Cleared Mar 05, 2013
COLS® FIXATION SYSTEM
K120740 · MBI
Fournitures Hospitalieres Industrie
Orthopedic · 358d
Cleared Mar 05, 2013
JMS SAFE WING CATH (SWC)
K121488 · FOZ
JMS North America Corporation
General Hospital · 291d
Cleared Mar 05, 2013
DENTOCORE / DENTOCORE BODY
K121769 · EBF
Itena Clinical
Dental · 263d
Cleared Mar 05, 2013
VIDAS LYME IGG
K122986 · LSR
Biomerieux S.A.
Microbiology · 160d
Cleared Mar 05, 2013
FORTIVA PORCINE DERMIS
K123356 · FTM
Rti Biologics, Inc.
General & Plastic Surgery · 125d
Cleared Mar 05, 2013
BIOMONDE LARVAE
K123449 · NQK
Biomonde (A Trading Name of Zoobiotic...
General & Plastic Surgery · 116d
Cleared Mar 05, 2013
CALLISTO EYE
K123464 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 116d
Cleared Mar 05, 2013
CIMVA UNIVERSAL
K123472 · MHX
Therapeutic Monitoring Systems (Tms),...
Cardiovascular · 112d
Cleared Mar 05, 2013
MULTIPLE NAME
K123819 · LYY
Top Calibre Sdn Bhd
General Hospital · 83d
Cleared Mar 05, 2013
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · MTD
Biosense Webster, Inc.
Cardiovascular · 82d
Cleared Mar 05, 2013
RESTORELLE Y CONTOUR
K123914 · OTO
Coloplast A/S
Obstetrics & Gynecology · 76d
Cleared Mar 05, 2013
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
K123980 · NRB
Misonix, Inc.
General & Plastic Surgery · 69d
Cleared Mar 05, 2013
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K123993 · OVD
Alphatec Spine, Inc.
Orthopedic · 69d
Cleared Mar 05, 2013
SUPERIOR LATERAL VARIAX CLAVICLE PLATE
K130116 · HRS
Stryker Trauma AG
Orthopedic · 48d
Cleared Mar 04, 2013
INBONE ( I AND II) TOTAL ANKLE SYSTEMS
K123059 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 154d
Cleared Mar 04, 2013
DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION...
K123188 · JCX
Dornoch Medical Systems, Inc.
General & Plastic Surgery · 144d
Cleared Mar 04, 2013
AVENIR MULLER STEM
K123392 · LZO
Zimmer GmbH
Orthopedic · 122d
Cleared Mar 04, 2013
UCENTUM
K123717 · NKB
Ulrich GmbH & Co. KG
Orthopedic · 90d
Cleared Mar 04, 2013
URSA ANGIOGRAPHIC CATHETER
K123818 · DQO
Curative Medical Technology, Inc.
Cardiovascular · 82d
Cleared Mar 04, 2013
ACLEARA, THERACLEAR
K123889 · ONF
Theravant Corporation
General & Plastic Surgery · 76d
Cleared Mar 04, 2013
CURA COLLIMATOR
K123893 · IXI
Cura Medical Technologies, LLC
Radiology · 76d
Cleared Mar 04, 2013
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE...
K130307 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 25d