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
81745–81768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2000
SOMATOM SMILE
K003152 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 24, 2000
HEATED HUMIDIFIER
K983783 · BTT
Pegasus Research Corp.
Anesthesiology · 728d
Cleared Oct 23, 2000
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K000838 · LYY
P.T. Healthcare Glovindo
General Hospital · 223d
Cleared Oct 23, 2000
DMLC IV-ERGO
K001163 · IXI
3D Line USA, Inc.
Radiology · 196d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468 · MOI
Roche Diagnostics Corp.
Immunology · 166d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · HRX
Radionics, Inc.
Orthopedic · 137d
Cleared Oct 23, 2000
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
K001990 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 116d
Cleared Oct 23, 2000
MR-III
K002261 · GAS
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Oct 23, 2000
BROOKER FEMORAL NAILS
K002278 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 23, 2000
THERMAL CAUTERY UNIT, MODEL 150
K002341 · HQO
Geiger Medical Technologies, Inc.
Ophthalmic · 83d
Cleared Oct 23, 2000
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR...
K002389 · GXI
Baylis Medical Co., Inc.
Neurology · 80d
Cleared Oct 23, 2000
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K002446 · KXK
Sun Nuclear Corp.
Radiology · 75d
Cleared Oct 23, 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500 · KGI
Pronosco A/S
Radiology · 70d
Cleared Oct 23, 2000
REUSABLE CANNULA
K002542 · GCJ
Genicon, LC
General & Plastic Surgery · 68d
Cleared Oct 23, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · LPN
Alcon Universal, Ltd.
Ophthalmic · 63d
Cleared Oct 23, 2000
BIOSLEEP
K002622 · OLZ
Oxford Biosignals Limited
Neurology · 61d
Cleared Oct 23, 2000
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
K002631 · OLX
Eemagine Medical Imaging Solutions GmbH
Neurology · 61d
Cleared Oct 23, 2000
NEUROMAP WITH NEURO 100
K002773 · GWF
Radionics, Inc.
Neurology · 47d
Cleared Oct 23, 2000
KSEA NEURO-FIBERSCOPE
K002788 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 46d
Cleared Oct 23, 2000
WHEELCHAIR, MECHANICAL SERIES MODEL 3100
K002943 · IOR
Mada Medical Products, Inc.
Physical Medicine · 32d
Cleared Oct 23, 2000
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 23, 2000
AERO-CLICK
K993094 · BZD
Map Medizintechnik Fur Arzt Und...
Anesthesiology · 403d
Cleared Oct 20, 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 267d
Cleared Oct 20, 2000
DA VINCHI EEG AND EMG/EP SYSTEMS
K000963 · GWF
Airsep Corp.
Neurology · 210d