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

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175,820 results
44257–44280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2012
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
K121380 · GCJ
Teleflexmedical, Inc.
General & Plastic Surgery · 17d
Cleared May 24, 2012
PRAEZIS PLUS
K110644 · HAW
Tatramed Spol. S.R.O.
Neurology · 444d
Cleared May 24, 2012
RHEA CUP
K112165 · HHE
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 301d
Cleared May 24, 2012
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
K112491 · GKA
Sebia
Hematology · 269d
Cleared May 24, 2012
TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM
K112585 · DZE
Adin Dental Implants System, Ltd.
Dental · 261d
Cleared May 24, 2012
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K112905 · MBF
Biomet Orthopedics, LLC
Orthopedic · 234d
Cleared May 24, 2012
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
K120079 · BTO
Primed Halberstadt Medizintechnik GmbH
Anesthesiology · 135d
Cleared May 24, 2012
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
K120118 · CAP
Ventlab Corp.
Anesthesiology · 128d
Cleared May 24, 2012
DUAL SPIKE TRANSFER DEVICE
K120150 · LHI
B.Braun Medical, Inc.
General Hospital · 127d
Cleared May 24, 2012
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · MTD
Biosense Webster, Inc.
Cardiovascular · 101d
Cleared May 24, 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · JXG
Aesculap, Inc.
Neurology · 90d
Cleared May 24, 2012
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN...
K120601 · NPM
Geistlich Pharma AG
Dental · 86d
Cleared May 24, 2012
MAYFIELD SKULL CLAMP
K120633 · HBL
Integra LifeSciences Corporation
Neurology · 84d
Cleared May 24, 2012
ES BOND
K120767 · KLE
Spident Co., Ltd.
Dental · 71d
Cleared May 24, 2012
LEKSELL GAMMA KNIFE PERFEXION
K120811 · IWB
Elekta Instrument AB
Radiology · 69d
Cleared May 24, 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 65d
Cleared May 24, 2012
REMOTE PRESENCE SYSTEM
K120895 · DRG
Intouch Health, Inc.
Cardiovascular · 62d
Cleared May 24, 2012
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
K121232 · DBF
Kamiya Biomedical Company
Immunology · 30d
Cleared May 24, 2012
PAX-DUO3D PLUS, PCT-5000
K121236 · OAS
VATECH Co., Ltd.
Radiology · 30d
Cleared May 24, 2012
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS...
K121239 · LNH
Optoacoustics, Ltd.
Radiology · 30d
Cleared May 23, 2012
LUCENT OR LUCENT MAGNUM
K110632 · MAX
Spinal Elements, Inc.
Orthopedic · 446d
Cleared May 23, 2012
ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/...
K111262 · GEI
Olsen Medical
General & Plastic Surgery · 384d
Cleared May 23, 2012
CONTOUR TECHNOLOGY MUSCLE STIMULATOR
K111476 · NGX
Contour Technology
Physical Medicine · 362d
Cleared May 23, 2012
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
K111575 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 352d