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
44641–44664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2012
RADIOGRAPHIC X-RAY SYSTEM
K120034 · KPR
Orich Medical Equipment (Tianjin Co.,...
Radiology · 104d
Cleared Apr 17, 2012
INTRAOSSEOUS FIXATION SYSTEM
K120165 · HTY
Orthohelix Surgical Designs, Inc.
Orthopedic · 89d
Cleared Apr 17, 2012
3MENSIO WORKSTATION
K120367 · LLZ
Pie Medical Imaging BV
Radiology · 71d
Cleared Apr 17, 2012
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
K120591 · JIT
Diamond Diagnostics, Inc.
Chemistry · 49d
Cleared Apr 17, 2012
INZONE DETACHMENT SYSTEM
K120816 · KRD
Stryker
Cardiovascular · 29d
Cleared Apr 17, 2012
TARGET DETACHABLE COIL
K120850 · HCG
Stryker Neurovascular
Neurology · 27d
Cleared Apr 17, 2012
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
K121001 · JOW
Novitas Medical, LLC
Cardiovascular · 15d
Cleared Apr 16, 2012
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 480d
Cleared Apr 16, 2012
SUPERCATH Z3V
K112290 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 251d
Cleared Apr 16, 2012
TRANSCORP SPINAL ACCESS SYSTEM
K113352 · HRX
Transcorp, Inc.
Orthopedic · 154d
Cleared Apr 16, 2012
ESCALATE LAMINOPLASTY SYSTEM
K113802 · NQW
Stryker Spine
Orthopedic · 115d
Cleared Apr 16, 2012
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · KCT
Codman & Shurtleff, Inc.
General Hospital · 90d
Cleared Apr 16, 2012
OP SPINE SYSTEM
K120291 · OSH
OrthoPediatrics Corp.
Orthopedic · 76d
Cleared Apr 16, 2012
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
K120403 · GCJ
Transenterix, Inc.
General & Plastic Surgery · 67d
Cleared Apr 16, 2012
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K120830 · FRN
Carticept Medical, Inc.
General Hospital · 28d
Cleared Apr 13, 2012
CLEARVISION DR 7000F
K102327 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 605d
Cleared Apr 13, 2012
INTRABEAM NEEDLE APPLICATOR
K110590 · JAD
Carl Zeiss Surgical GmbH
Radiology · 408d
Cleared Apr 13, 2012
SMARTEPIL,DEPILASE YAG LASE PLUS
K112141 · GEX
Castle Laser Systems, Limited
General & Plastic Surgery · 262d
Cleared Apr 13, 2012
NUVASIVE NVJJB SYSTEM
K112717 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 207d
Cleared Apr 13, 2012
MICRO I
K113096 · BZG
Carefusion Germany 234 GmbH
Anesthesiology · 177d
Cleared Apr 13, 2012
MECHANICAL WHEELCHAIR
K120032 · IOR
Aikin Healthcare Co., Ltd.
Physical Medicine · 100d
Cleared Apr 13, 2012
DRX-REVOLUTION MOBILE X-RAY SYSTEM
K120062 · IZL
Carestream Health, Inc.
Radiology · 95d
Cleared Apr 13, 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · KWQ
Globus Medical, Inc.
Orthopedic · 93d
Cleared Apr 13, 2012
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
K120135 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 87d