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

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176,076 results
57145–57168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2008
ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
K073343 · DZE
Ace Surgical Supply Co., Inc.
Dental · 106d
Cleared Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 13, 2008
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
K073567 · LZO
Zimmer GmbH
Orthopedic · 84d
Cleared Mar 13, 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · MSS
Staar Surgical Co.
Ophthalmic · 84d
Cleared Mar 13, 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · MSS
Staar Surgical Co.
Ophthalmic · 84d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT...
K073604 · CEC
Dade Behring, Inc.
Chemistry · 83d
Cleared Mar 13, 2008
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
K073623 · ITX
Boston Scientific Corp
Radiology · 78d
Cleared Mar 13, 2008
TINNITUS SOUND GENERATOR MODULE
K073636 · KLW
Gn Resound A/S
Ear, Nose, Throat · 78d
Cleared Mar 13, 2008
MOUNTABLE ENDOSCOPIC BLADE
K080133 · EMF
A.M. Surgical, Inc.
General & Plastic Surgery · 55d
Cleared Mar 13, 2008
MODIFICATION TO REBOUND HRD
K080393 · FTL
Minnesota Medical Development, Inc.
General & Plastic Surgery · 29d
Cleared Mar 13, 2008
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
K080394 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · MNI
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Mar 13, 2008
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
K080461 · MLD
Philips Medical Systems
Cardiovascular · 22d
Cleared Mar 13, 2008
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9,...
K080500 · DYB
Acumen Medical, Inc.
Cardiovascular · 17d
Cleared Mar 13, 2008
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
K080540 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Mar 12, 2008
SLENDERTONE ENERVIVE, MODEL 561
K071666 · NGX
Bio-Medical Research Corp.
Physical Medicine · 268d
Cleared Mar 12, 2008
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR
K072197 · LZC
Metacure Surgical Gloves Sdn Bhd
General Hospital · 218d
Cleared Mar 12, 2008
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION...
K072256 · PFW
Hill Laboratories Co.
Physical Medicine · 212d
Cleared Mar 12, 2008
STERILS SINGLE-USE I/A HANDPIECES
K073023 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 138d
Cleared Mar 12, 2008
AMICAS VISION SERIES PACS, MODEL 5.5
K073526 · LLZ
Amicas, Inc.
Radiology · 86d
Cleared Mar 12, 2008
DUAL CHAMBER TPN CONTAINER
K073538 · KPE
B.Braun Medical, Inc.
General Hospital · 86d
Cleared Mar 12, 2008
DANYANG HUAYI K2 AND K7 WHEELCHAIRS
K080207 · IOR
Danyang Huayi Medical Supply &...
Physical Medicine · 44d
Cleared Mar 12, 2008
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+...
K080352 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 30d
Cleared Mar 11, 2008
DRAEGER ALCOTEST 6510
K063443 · DJZ
Drager Safety
Chemistry · 483d