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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
59689–59712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2007
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
K070399 · JDI
Biomet Manufacturing, Inc.
Orthopedic · 81d
Cleared May 04, 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · NDN
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared May 04, 2007
APEX MEDICAL XT1 CPAP, MODEL 9S-005
K070609 · BZD
Apex Medical Corp.
Anesthesiology · 60d
Cleared May 04, 2007
CORSCREEN
K070614 · DPS
Viasys Healthcare GmbH
Cardiovascular · 60d
Cleared May 04, 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070615 · LJS
AngioDynamics, Inc.
General Hospital · 60d
Cleared May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
K070626 · NQD
Beckman Coulter, Inc.
Chemistry · 59d
Cleared May 04, 2007
NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
K070681 · KWQ
Alphatec Spine, Inc.
Orthopedic · 53d
Cleared May 04, 2007
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1,...
K070741 · JJY
Cliniqa Corporation
Chemistry · 49d
Cleared May 04, 2007
REUNION HA FRACTURE STEM
K070963 · HSD
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared May 04, 2007
ORTHADAPT BIOIMPLANT
K071065 · FTM
Pegasus Biologics, Inc.
General & Plastic Surgery · 18d
Cleared May 03, 2007
MONOLISA ANTI-HAV EIA
K063318 · LOL
Bio-Rad Laboratories
Microbiology · 182d
Cleared May 03, 2007
MONOLISA ANTI-HAV IGM EIA
K063319 · LOL
Bio-Rad Laboratories
Microbiology · 182d
Cleared May 03, 2007
AUTOVENT MODEL 4000
K070120 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 111d
Cleared May 03, 2007
RANGE SPINAL SYSTEM
K070229 · MNI
K2m, Inc.
Orthopedic · 99d
Cleared May 03, 2007
IPC-BOOT
K070324 · JOW
C-Boot , Ltd.
Cardiovascular · 87d
Cleared May 03, 2007
100KGY E-POLY MAXROM ACETABULAR LINERS
K070364 · JDI
Biomet, Inc.
Orthopedic · 85d
Cleared May 03, 2007
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635,...
K071055 · DYW
Ultradent Products, Inc.
Dental · 17d
Cleared May 02, 2007
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL...
K052480 · DXX
Hansen Medical, Inc.
Cardiovascular · 600d
Cleared May 02, 2007
PRODERMA LIQUID BANDAGE
K063202 · KMF
Procurement Technology Systems, LLC
General & Plastic Surgery · 194d
Cleared May 02, 2007
ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
K070193 · DQA
Envitec-Wismar GmbH
Anesthesiology · 100d
Cleared May 02, 2007
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
K070307 · ELC
Dentsply International, Inc.
Dental · 90d
Cleared May 02, 2007
KELSEY INTERSITITAL LASER THERAPY SYSTEM
K070353 · GEX
Kelsey, Inc.
General & Plastic Surgery · 85d
Cleared May 02, 2007
PROFILE MULTI-PLATFORM SYSTEM
K070388 · GEX
Sciton, Inc
General & Plastic Surgery · 82d
Cleared May 02, 2007
COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
K070446 · GEI
Valleylab,A Division of Tyco...
General & Plastic Surgery · 76d